AMPLATZER™ 9-ITV06F180/80Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00811806010779), received between Sep 24, 2018 and Sep 17, 2026 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Deformation

  It was reported that on (b)(6)2026, a 6mm X 4 mm Amplatzer PDA occluder was chosen for implant using a 6F Amplatzer Torqvue Delivery System. The PDA was measured at 2 mm. The patient did not have tortuous anatomy. The delivery sheath was inspected prior to use, and no damage, kinks, or obstructions were observed. The device was flushed and prepared according to the Instructions for Use (IFU) prior to delivery. During the first deployment attempt, it was noted that the retention disc of the PDA device was successfully opened and positioned across the PDA. However, the device position was deemed unsatisfactory. The physician attempted to recapture the device for repositioning but experienced difficulty retrieving the device into the sheath. Upon inspection, the tip of the sheath was found to be bent, which hindered device retrieval. Additional force was applied, and the device was successfully recaptured and withdrawn into the sheath. The 6F sheath was then exchanged for a new 7F Amplatzer Torqvue Delivery System (Lot No. 11309053). The device was flushed, reloaded, and redeployed. The second deployment was successful, and the device was implanted in the desired position. The procedu

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801584 ↗
• MalfunctionSep 9, 2026Material Deformation

  It was reported that on (b)(6) 2026, an 8-6mm Amplatzer Duct Occluder was chosen for implant using a 6F Amplatzer Torqvue delivery system for Patent Ductus Arteriosus (PDA) closure. Prior to use, the delivery sheath was inspected for damage, kinks, or obstructions, and the device was flushed and prepared according to the Instructions for Use (IFU). During the procedure, a cobra-head configuration of the occluder was observed. The occluder and delivery system were flushed and immersed in saline solution three times. Following each flush, the occluder was recaptured into the delivery system and redeployed in an attempt to restore the device configuration. Despite these efforts, the device did not return to its original configuration. The deformed device was never released from the delivery cable while inside the patient. It was reported that there was no angulation or kink in the delivery system and no interaction with cardiac structures during deployment. On the final recapture attempt, the tip of the TorqVue delivery system was damaged, rendering the delivery system unusable. As a result, both the Amplatzer Duct Occluder and the 6F Amplatzer TorqVue Delivery System were removed and

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50693698 ↗
• MalfunctionDec 22, 2025Fracture; Device Difficult to Setup or Prepare; Retraction Problem; Fracture; Device Difficult to Setup or Prepare; Retraction Problem

  IT WAS REPORTED ON (B)(6) 2025 A 10-8MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. ALL STEPS WERE PERFORMED PER INSTRUCTIONS FOR USE (IFU). DURING THE PROCEDURE IT WAS NOTED THAT THE OCCLUDER COULD NOT BE RETRACTED INTO THE DELIVERY SYSTEM. THE HEMOSTASIS VALVE ALSO APPEARED TO BE CRACKED. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND REPLACED WITH A NEW 7F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865782 ↗
• MalfunctionNov 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. DURING DEVICE PREPARATION, IT WAS OBSERVED THAT THE TUBING WAS CRACKED AND LEAKING SALINE DURING FLUSHING. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649532 ↗
• InjurySep 17, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED ON 19 AUGUST 2025 A 6F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR A PROCEDURE. DURING THE PROCEDURE WHILE ATTEMPTING TO INSERT THE DELIVERY SYSTEM INTO THE EASTER ACCESS POINT THE DELIVERY SYSTEM WAS STUCK AND COULD NOT BE ADVANCED. THE RELEASE MECHANISM WAS ABLE TO BE INSERTED, HOWEVER THE SHEATH COULD NOT. SEVERAL ATTEMPTS WERE MADE TO INSERT THE DELIVERY SHEATH BUT WERE UNSUCCESSFUL. WHILE CHANGING THE DELIVERY SHEATH, CONTRAST ANGIOGRAPHY WAS PERFORMED ON THE ACCESS SITE REVEALING A DISSECTION OF THE RIGHT FEMORAL VEIN. THE PROCEDURE WAS ABORTED IN ORDER TO TREAT THE VEIN DISSECTION. THE DISSECTION WAS COMPRESSED UNTIL THE DISPERSION OF FLOW IN THE ANGIOGRAM WAS NO LONGER OBSERVED. THE PATIENT STATUS WAS STABLE. THE USER BELIEVED THE DELIVERY SYSTEM CAUSED THE DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 23075736 ↗
• MalfunctionMay 20, 2025Difficult to Insert; Material Split, Cut or Torn; Difficult to Insert; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR USE. THE PATIENT DID NOT HAVE A TORTUOUS ANATOMY. DURING PROCEDURE, THE GUIDEWIRE HAD PASSED THROUGH THE CATHETER. ONCE THE CATHETER WAS INTRODUCED INTO THE PATIENT, IT WAS OBSERVED THAT THE TIP WAS DAMAGED; THE CATHETER WOULD NOT TRACK OVER THE WIRE. IN ADDITION, IT APPEARED THAT "THE LOADER SEEMED TO BE THE WRONG SIZE." THE DEVICE WOULD NOT PASS INTO THE CATHETER VIA THE LOADER. THE USER ALLEGED THAT THE TIP DAMAGE OCCURRED WHEN THE CATHETER WAS INTRODUCED INTO THE GROIN. THEREFORE, BOTH THE TORQVUE AND THE LOADER WERE EXCHANGED FOR UNKNOWN REPLACEMENT DEVICES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22057786 ↗
• MalfunctionMay 1, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2025 A 6F AMPLATZER TORQVUE DELIVERY SYSTEM WAS SELECTED FOR A PROCEDURE TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA). DURING THE PROCEDURE IT WAS NOTED THAT THE DELIVERY SYSTEM WAS LEAKING. THERE WAS CONCERN WITH AIR POTENTIALLY BEING INTRODUCED TO THE PATIENT. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND INSPECTED. A SPLIT ON THE SIDE OF THE CONNECTOR WAS OBSERVED. THE CONNECTION PART WAS REPLACED AND THE SAME DELIVERY SYSTEM WAS USED FOR COMPLETION OF THE PROCEDURE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21944653 ↗
• MalfunctionApr 25, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6F AMPLATZER TORQVUE DS WAS SELECTED FOR USE IN AN IMPLANT PROCEDURE. DURING DEVICE PREP, IT WAS NOTED THAT THE 5-4MM AMPLATZER PDA OCCLUDER WASN'T ABLE TO FIT INTO THE DS, SO THE OCCLUDER AND DS WERE DAMAGED. THE DS WAS REPLACE WITH A 7F AMPLATZER TORQVUE DS TO RESOLVE THE EVENT. THE PROCEDURE TIME WAS DELAYED BECAUSE THE DEVICE DID NOT ADVANCE FROM THE DELIVERY CABLE, AND UNPLANNED BLEEDING OCCURRED DURING THE CABLE REPLACEMENT PROCESS. THE PATIENT HAS NOW RECOVERED AND BEEN DISCHARGED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21910128 ↗
• MalfunctionFeb 25, 2025Retraction Problem; Device Damaged by Another Device; Separation Problem; Retraction Problem; Device Damaged by Another Device; Separation Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A 6-4MM AMPLATZER PATENT DUCTUS ARTERIOSUS (PDA) OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEVICE PREPARATION THE OCCLUDER WAS ROTATED COUNTER-CLOCKWISE 1/8 OF ONE TURN TO FACILITATE DEVICE RELEASE UPON DEPLOYMENT, AS PER THE INSTRUCTIONS FOR USE. IT WAS NOTED DURING PROCEDURE THAT THE OCCLUDER WAS UNABLE TO BE DETACHED FROM THE DELIVERY CABLE, EVEN AFTER MULTIPLE ATTEMPTS. THE PHYSICIAN DID CHECK THE CABLE CONNECTION AND THE DELIVERY CABLE WAS NOT AT AN EXTREME ANGLE IN RELATION TO THE DISC. THE DECISION WAS MADE TO RECAPTURE AND REMOVE THE 6-4MM AMPLATZER (PDA) OCCLUDER. IT'S NOTED AFTER RECAPTURE AND REMOVAL OF OCCLUDER, THAT THE 6F AMPLATZER TORQVUE DELIVERY SYSTEM HAD SLIGHT WARPING/DAMAGE. THE DECISION WAS MADE TO REPLACE THE 6-4MM AMPLATZER (PDA) OCCLUDER WITH ANOTHER ONE OF THE SAME SIZE AND 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. THE PATIENT WAS STABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21461855 ↗
• MalfunctionSep 27, 2024Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6F AMPLATZER TORQVUE DELIVERY SYSTEM WAS CHOSEN FOR PROCEDURE TO IMPLANT AN AMPLATZER DUCT OCCLUDER. AFTER DEPLOYING THE OCCLUDER, THE DEVICE WAS NOT ABLE TO BE RETRACTED BACK INTO THE DELIVERY SHEATH. THE DISC WOULD NOT GO BACK INTO THE SHEATH. AN EXCHANGE SYSTEM WAS USED, AND THE DEVICE WAS ABLE TO BE FULLY RETRACTED PRIOR TO REMOVAL FROM THE PATIENT. AFTER THE SHEATH WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT THERE WAS A SMALL KINK AT THE OPENING OF THE SHEATH, WHICH WAS THE REASON WHY THE DEVICE COULD NOT BE RETRACTED INTO THE SHEATH. THE DEVICE WAS REPLACED WITH ANOTHER 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20322626 ↗
• MalfunctionApr 22, 2024Material Invagination; Retraction Problem; Material Invagination; Retraction Problem

  IT WAS REPORTED THAT ON 28 MARCH 2024, A 5MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANTATION UTILIZING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM (9-ITV06F180/80 LOT: 8979325). DURING IMPLANTATION A RE-SHEATH WAS ATTEMPTED TO RE-OPTIMIZE POSITIONING, HOWEVER THE OCCLUDER COULD NOT BE FULLY RETRACTED. THE SHEATH TIP WAS OBSERVED TO BE INVAGINATED. THE DELIVERY SYSTEM AND OCCLUDER WERE REMOVED FROM THE PATIENT WITHOUT BEING FULLY RE-SHEATHED. NO SURGICAL INTERVENTION WAS NECESSARY. A REPLACEMENT AMPLATZER TORQVUE ( 9-TVLP5F90/080 LOT 8435188) AND AMPLATZER DUCT OCCLUDER II (9-PDA2-05-04 LOT 8719681) WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152357 ↗
• MalfunctionMar 28, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT AN 5-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2024 USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE IT WAS NOTED THAT THE DEVICE WAS UNABLE TO BE RETRACTED INTO THE DELIVERY SYSTEM FOR A RECAPTURE. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE DELIVERY SYSTEM WAS REPLACED WITH A NEW 6F AMPLATZER TORQVUE DELIVERY SYSTEM. THE PATIENT DID NOT PRESENT WITH ANY CLINICAL SIGNS OR SYMPTOMS. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992551 ↗
• MalfunctionFeb 28, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2024, A 6F AMPLATZER TORQVUE DS WAS SELECTED TO IMPLANT A DEVICE. THE DELIVERY SYSTEM WAS DEFORMED AT THE TOP OF THE SHEATH DURING THE PROCEDURE. THE DAMAGE WAS NOTED DURING THE SECOND ADVANCEMENT OF THE DELIVERY SYSTEM THROUGH THE FEMORAL ACCESS. THE FIRST ADVANCEMENT WAS SUCCESSFUL, HOWEVER DURING THE PROCEDURE IT WAS NECESSARY TO REPOSE AND INSERT IT ONCE AGAIN. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND WAS REPLACED BY 7F AMPLATZER TORQVUE DS AND THE DEVICE WAS SUCCESSFULLY IMPLANTED . THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICAL SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE EVENTS FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18799158 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 6-4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT ON (B)(6) 2023 USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO CLOSE A TYPE A PATENT DUCTUS ARTERIOSUS. DURING IMPLANT, THE PATIENT'S BLOOD PRESSURE DROPPED TO 50MMHG IN A TRANSIENT MANNER WHEN THE DELIVERY SYSTEM CROSSED THE TRICUSPID VALVE. THE OCCLUDER AND DELIVERY SYSTEM WERE REMOVED AND REPLACED WITH A NEW 5-4MM AMPLATZER DUCT OCCLUDER AND 5F AMPLATZER TORQVUE DELIVERY SYSTEM.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 18517653 ↗
• InjuryJul 17, 2023Difficult to Insert; Premature Separation; Difficult to Insert; Premature Separation

  IT WAS REPORTED THAT ON (B)(6) 2023, AN 8-6MM AMPLATZER DUCT OCCLUDER WAS CHOSEN FOR IMPLANT USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM TO CLOSE A PATENT DUCTUS ARTERIOSUS (PDA). THE PDA MEASURED 4MM AT THE DISTAL PULMONARY ARTERY END WITH A SMALL TAIL-LIKE RUNOFF. THERE WAS DIFFICULTY ACCESSING THE WIRE THROUGH THE DEFECT. A PERIPHERAL BALLOON WAS USED TO DILATE THE DISTAL END OF THE PDA. THE DEVICE FELT TIGHT ENTERING INTO THE DELIVERY SYSTEM FROM THE LOADER. THE OCCLUDER DETACHED FROM THE DELIVERY CABLE ABOUT 2/3 OF THE LENGTH OF THE DELIVERY SYSTEM, AND THE PHYSICIAN FELT THE CABLE DISCONNECT. FLUOROSCOPY SHOWED THAT THE DEVICE HAD PREMATURELY DETACHED FROM THE DELIVERY CABLE. THE AORTIC DISC WAS SITTING ON THE AORTIC SIDE OF THE DEFECT. THE PATIENT WAS THEN CONVERTED TO GENERAL ANESTHESIA DUE TO DISCOMFORT DURING THE PROCEDURE. A SNARE WAS PLACED UP THE ARTERIAL SIDE, AND THE AORTIC DISC WAS SNARED. A GUIDEWIRE AND SMALL BALLOON WERE PLACED UP THE VENOUS SIDE TO TRAP THE DEVICE. THE DEVICE WAS NOT ABLE TO BE PULLED BACK INTO THE GUIDE CATHETER, SO ANOTHER SNARE WAS PLACED UP THE VENOUS SIDE TO SNARE THE SKIRT OF THE DEVICE. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIEN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17336736 ↗
• MalfunctionMay 1, 2023Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, A 10MM BY 8MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANTATION USING A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING THE PROCEDURE, DURING DEPLOYMENT, IT WAS DECIDED THAT THE DEVICE WAS TOO LARGE FOR PATIENT ANATOMY. WHEN IT WAS ATTEMPTED TO REMOVED THE DEVICE FROM PATIENT ANATOMY, IT WAS FOUND THAT THE DEVICE WOULD NOT RETRACT BACK INTO THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS THEN CAREFULLY RETRACTED FROM PATIENT ANATOMY WITH THE DEVICE STICKING OUT OF THE END. THE DEVICE WAS REPLACED WITH AN 8MM BY 6MM AMPLATZER DUCT OCCLUDER USING A NEW 6F AMPLATZER TORQVUE DELIVERY SYSTEM WITH THE SAME LOT NUMBER. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THE PATIENT IS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16846978 ↗
• InjuryJul 25, 2022Retraction Problem; Patient-Device Incompatibility; Retraction Problem; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, AN 8MM AMPLATZER VSD MUSCULAR OCCLUDER WAS SELECTED FOR IMPLANT USING A 6F AMPLATZER ITV DELIVERY SYSTEM. THE DEVICE WAS SIZED USING TRANSTHORACIC ECHOCARDIOGRAM (TTE) AND FLURO IMAGING. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DEVICE INTO THE DELIVERY SHEATH, HOWEVER THE SECOND DISC WAS NOT RE-SHEATHING DUE TO UNKNOWN CAUSES. A CUT DOWN PROCEDURE FROM THE JUGULAR VEIN WAS PERFORMED AND A LARGER SHEATH WAS PLACED INSIDE THE VEIN AND THE DELIVERY SHEATH AND DEVICE WERE PULLED UP USING THE LARGER SHEATH. THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. A NEW 10MM AMPLATZER VSD MUSCULAR OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT STATUS WAS REPORTED AS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15099578 ↗
• MalfunctionMar 1, 2020Mechanical Problem; Retraction Problem; Mechanical Problem; Retraction Problem

  RELATED MANUFACTURER REFERENCE NUMBER 2135147-2020-00086. ON (B)(6) 2020, AN 8MM AMPLATZER MUSCULAR VSD WAS ATTEMPTED TO BE IMPLANTED. IT WAS MIS-SIZED TOO SMALL AND EXCHANGED FOR A 10MM AMPLATZER MUSCULAR VSD OCCLUDER (LOT # 6925807) WITH A 6F AMPLATZER TORQVUE DELIVERY SYSTEM. WHEN POSITIONING THE DEVICE, IT WAS DETERMINED TO BE MI-SIZED TOO SMALL. WHEN ATTEMPTING TO RETRACT THE DEVICE, THE DEVICE WOULD NOT RE-SHEATH NOR RETRACT INTO THE 6F DELIVERY SHEATH AND A VASCULAR ISSUE OCCURRED WITH HEMATOMA AT THE GROIN. THE DEVICE AND THE DELIVERY SYSTEM WAS REMOVED AND THE DELIVERY SYSTEM WAS EXCHANGED FOR AN 8F TORQVUE 45/80 DELIVERY SYSTEM (LOT # UNKNOWN) AND A NEW 10MM MUSCULAR VSP (LOT # 6942246). THE PHYSICIAN NOTED THAT THE PATIENT HAD A TORTUROUS ANATOMY AND THERE WAS NO KINKS NOTED ON THE FIRST DELIVERY SYSTEM (LOT # 6271477). THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT IS STABLE DURING AND POST PROCEDURE.

  Patient problems: Hematoma

  MAUDE report 9772694 ↗
• InjuryAug 15, 2019Retraction Problem; Material Twisted/Bent; Retraction Problem; Material Twisted/Bent

  RELATED MANUFACTURER REPORT NUMBER : 2135147-2019-00255. ON (B)(6) 2019, AN AMPLATZER MUSCULAR VSD OCCLUDER WAS SELECTED FOR IMPLANT. THE DEVICE WAS DEPLOYED BUT DIDN'T FIT THE VENTRICULAR SEPTAL DEFECT. THE DEVICE WAS ATTEMPTED TO BE RETRACTED, BUT THE OCCLUDER DIDN'T COLLAPSE AND RETRACT INTO THE DELIVERY SHEATH. THE TIP OF THE DELIVERY SHEATH KEPT FOLDING IN ON ITSELF. MEANWHILE, THE PATIENT WENT INTO COMPLETE HEART BLOCK AND BECAME HYPOTENSIVE. THE OCCLUDER AND DELIVERY SYSTEM WERE WITHDRAWN FROM THE PATIENT WITHOUT COLLAPSING THE OCCLUDER. THE PROCEDURE WAS CANCELLED AND THE PATIENT WAS SENT TO THE PEDIATRIC INTENSIVE CARE UNIT FOR CONTINUED MONITORING. THE HEART BLOCK RESOLVED WITHOUT TREATMENT.

  Patient problems: Complete Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 8897452 ↗
• MalfunctionJul 15, 2019Break; Break

  ON (B)(6) 2019, A 4MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT IN THE DUCTUS USING A 6F 180/80MM AMPLATZER TORQVUE DELIVERY SYSTEM (LOT NUMBER: 6942209). WHILE RELEASING THE DEVICE, THE SITE HAD DIFFICULTY LOOSENING THE DELIVERY CABLE. THE CABLE SNAPPED OFF RATHER THEN UNSCREW, AND PART REMAINED CONNECTED TO THE DEVICE. THE PHYSICIAN ELECTED TO LEAVE THE DEVICE IN PLACE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791391 ↗
• InjurySep 24, 2018Retraction Problem; Retraction Problem

  ON (B)(6) 2018, A 6MM AMPLATZER DUCT OCCLUDER WAS SELECTED FOR IMPLANT IN AN INFANT WITH A 6FR AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEVICE PREPARATION, THERE WAS NO ISSUE LOADING THE DEVICE. DURING PLACEMENT, THE USER WAS UNABLE TO RE-SHEATH THE DEVICE AS THE OCCLUDER WAS CAUGHT ON THE SHEATH. DUE TO THE FAILURE TO RE-CAPTURE THE DEVICE, THE PATIENT WAS SENT FOR SURGICAL REMOVAL OF THE DEVICE WHERE THE SHEATH WAS EXCHANGED FOR A COOK SHEATH AND THE DEVICE WAS PULLED TO THE IVC AND RETRIEVED THROUGH THE COOK SHEATH. THE CASE WAS ABORTED WITHOUT CLOSURE OF THE DEFECT. THE DELIVERY SHEATH WAS INSPECTED AND OBSERVED TO BE INVAGINATED AT THE TERMINAL END.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7901930 ↗