Amplatz Super Stiff™ M001465240Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 08714729295723), received between Oct 17, 2018 and Jul 3, 2025 — classified as 11 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE GUIDEWIRE COATING WAS DISPLACED. AN AMPLATZ SUPER STIFF WAS SELECTED FOR USE. UPON OPENING THE PACKAGE, THE PHYSICIAN NOTED THAT THE COATING ON THE GUIDEWIRE WAS DISPLACED AND APPEARED DIFFERENT THAN WHAT THEY HAD SEEN IN THE PAST. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398210 ↗
• MalfunctionJun 2, 2025Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DAMAGE OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP PART OF THE WIRE WAS SHREDDED. THE WIRE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A NEW WIRE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22125702 ↗
• MalfunctionApr 18, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WOULD NOT RETRACT AND THE WIRE COATING NOTED TO BE SEPARATED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE WIRE INADVERTENTLY EXITED THROUGH A SIDE HOLE OF THE TUBE INSTEAD OF THE END HOLE AND COULD NOT BE RETRACTED. THE BILIARY TUBE SHOWED NO SIGNS OF ENCRUSTATION OR STICKINESS. A NON BSC CATHETER WAS UTILIZED TO RETRIEVE THE WIRE. UPON EXAMINATION, IT WAS NOTED THAT THE WIRE'S COATING OR FLAT-WIRE COIL HAD SEPARATED FROM THE INNER CORE OF THE WIRE. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATION AS RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21865733 ↗
• MalfunctionFeb 24, 2025Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Unraveled Material; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COATING ON WIRE WAS UNRAVELED, COMING OFF OF WIRE AND BREAKING. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21454113 ↗
• MalfunctionOct 15, 2024Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIP OF THE GUIDEWIRE WAS PEELING OFF. THIS 035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A URETERAL STENT PLACEMENT PROCEDURE TO TREAT A 99% STENOSED TARGET LESION. DURING THE PROCEDURE, WHEN WIRING WAS PERFORMED IN THE LESION, THE WIRE DID NOT ADVANCE EASILY. WHEN IT WAS REMOVED FROM THE BODY, THE COATING AT THE TIP WAS NOTED TO BE PEELING OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452422 ↗
• MalfunctionJun 28, 2024Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT THE GUIDEWIRE SHREDDED AND SNAPPED. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE TO IMPLANT A BILIARY STENT. THERE WAS DIFFICULT INSERTING THE AMPLATZ SUPER STIFF GUIDEWIRE THROUGH THE SHEATH. THE GUIDEWIRE SHREDDED AND THEN SNAPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632649 ↗
• InjuryFeb 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA ATTACHED VOLUNTARY MEDWATCH REPORT #MW5149958 THAT GUIDEWIRE DETACHMENT OCCURRED. AN AMPLATZ GUIDEWIRE WAS ADVANCED FOR TREATMENT IN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULATION. HOWEVER, DURING THE PROCEDURE, THE GUIDEWIRE WAS SHEARED OFF RESULTING IN THE NEED FOR ADDITIONAL INTERVENTION. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18772375 ↗
• InjuryJan 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. AN ST/035/145 (BX/1) AMPLATZ GUIDEWIRE WAS SELECTED FOR TREATMENT. WHEN IT WAS REMOVED, IT WAS DISCOVERED TO HAVE FRAYED. THE PHYSICIAN SCRUBBED TO REMOVE THE REST OF THE WIRE AS THEY IMPLANTED A STENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN A STABLE CONDITION.

  Patient problems: Foreign Body In Patient

  MAUDE report 18466203 ↗
• MalfunctionDec 21, 2023Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT GUIDEWIRE ENTRAPMENT OCCURRED. THE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR. A ST/035/145 (BX/5) AMPLATZ - PI GUIDEWIRE WAS ADVANCED FOR TREATMENT; HOWEVER, THERE WAS DIFFICULTY IN REMOVING THE DEVICE WHICH THEN GOT STUCK ON THE STENT. THE GUIDEWIRE WAS REMOVED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377731 ↗
• InjuryApr 18, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance; Difficult to Remove; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT AND REMOVAL DIFFICULTIES OCCURRED WHICH RESULTED IN ADDITIONAL INTERVENTION. THE PATIENT PRESENTED WITH HERNIATED DISC. THE TARGET LESION WAS LOCATED IN THE NON- TORTUOUS AND NON-CALCIFIED LUMBAR SPINE. A 035/145 AMPLATZ SUPER STIFF WIRE WAS SELECTED FOR USE. THE PHYSICIAN USED A METAL NEEDLE DURING INSERTION. A RESISTANCE WAS FELT DURING INSERTION OF THE DEVICE, AFTERWARDS, THE DEVICE STOPPED COMING OUT AND SWITCHED FROM THE NEEDLE CANNULA TO THE DILATOR. HOWEVER, RESISTANCE IN REMOVING THE DEVICE WAS ENCOUNTERED AND ABOUT 5 CM FROM THE TIP WAS DETACHED. AS A RESULT, THE TIP OF THE WIRE REMAINED IN THE BODY, AND IT TOOK A LONG TIME TO INCISE THE INTERVERTEBRAL DISC DRAINAGE SITE FROM THE BODY SURFACE USING AN ELECTROCAUTERY SCALPEL TO OPEN THE REMAINING PART. HENCE, THE DETACHED TIP WAS REMOVED FROM THE INTERVERTEBRAL DISC LOCATED BETWEEN THE LUMBAR VERTEBRAE. THE OPERATION WAS THEN SWITCHED TO REMOVING IT, RESULTING IN A LONG PROCEDURE, SO THE PROCEDURE WAS NOT COMPLETED. FOR THE PURPOSE OF DRAINING THE FLUID BETWEEN THE LUMBAR VERTEBRAL BODY. AN 18G CANNULA NEEDLE WAS USED TO IDENTIFY THE AREA BETWEEN THE VERTEBRAL BODY AND PUNCTURED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763872 ↗
• MalfunctionApr 11, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT COATING ISSUE OCCURRED. A 035/145 (BX/1) AMPLATZ SUPER STIFF GUIDEWIRE WAS USED. HOWEVER, DURING THE PROCEDURE, THE WIRE DELAMINATED AS THE COATING AT THE DISTAL TIP OF THE WIRE SEPARATED AND PEELED OFF FROM ITS COATING. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16714588 ↗
• MalfunctionMar 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE FRACTURE OCCURRED. A 035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531719 ↗
• MalfunctionFeb 20, 2023Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JAN2023. IT WAS REPORTED THAT GUIDEWIRE UNRAVELED WAS ENCOUNTERED. A 035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS USED DURING PROCEDURE. HOWEVER, IT WAS NOTICED THAT THE DEVICE WAS UNRAVELED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED GUIDEWIRE DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16403430 ↗
• InjuryFeb 14, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND GUIDEWIRE DETACHMENT OCCURRED; PATIENT EXPERIENCED DISCOMFORT. A ST/035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE DRAINAGE PROCEDURE, A DISCOMFORT WAS FELT WHEN THE WIRE WAS PULLED OUT FROM THE CATHETER. THE DEVICE WAS REMOVED FROM THE CATHETER BY FORCIBLY PULLING IT OUT. IT WAS FELT THAT THE CORE PART WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 16376592 ↗
• MalfunctionFeb 6, 2023Unraveled Material; Unraveled Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31JAN2023. IT WAS REPORTED THAT UNRAVELED GUIDEWIRE OCCURRED. A 35/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, UPON OPENING THE PACKAGE, IT WAS NOTICED THAT THE WIRE WAS ALREADY FRAYED OFF. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, MEDIA ANALYSIS REVEALED A CORE WIRE DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16307150 ↗
• InjuryJan 31, 2023Unraveled Material; Detachment of Device or Device Component; Device-Device Incompatibility; Unraveled Material; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN REMOVING THE GUIDEWIRE, IT BECAME STUCK ON THE STENT CAUSING IT TO UNRAVEL AND SEPARATE LEAVING A PORTION OF THE TIP UNRETRIEVABLE INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND NON-CALCIFIED BILE DUCT. A ST/035/145 (BX/5) AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED FOR TREATMENT OF BILIARY STRICTURE ANGIOPLASTY AND STENTING, AND ALSO REMOVAL OF PREVIOUSLY PLACED 6FG PIGTAIL DRAIN. DURING THE FINAL PART OF STENTING A BILIARY OBSTRUCTION WHEN REMOVING THE WIRE, IT GOT CAUGHT ON THE FAR END OF THE STENT AND UNRAVELED (DETACHED TIP WAS SEEN ON IMAGING IN THE DUODENUM). NO ATTEMPT WAS MADE TO RETRIEVE FRAGMENT BECAUSE IT WAS IN THE DUODENUM AND IF FREE MAY BE EXPECTED TO PASS WITHOUT COMPLICATION. IF THE FRAGMENT WAS STILL ATTACHED TO THE STENT, ANY ATTEMPTS TO REMOVE MAY DISLODGE STENT (IN NON-TORTUOUS LOCATION). IT WAS NOTED THAT ONLY 3 CM LENGTH OF WIRE WAS VISIBLE ON X-RAY EXPOSURE WAS DIFFICULT TO SEE ON FLUOROSCOPY. THE PROCEDURE HAD ALREADY BEEN COMPLETED BEFORE THIS OCCURRED, THUS PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADDITIONAL INTERVENTIONS AS A RESULT, AND THE PATIENT HAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16275569 ↗
• MalfunctionJan 11, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED VIA USER FACILITY MEDWATCH # (B)(4) THAT GUIDEWIRE DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH GALLSTONES AND UNDERWENT A CHOLE TUBE AND BILIARY DRAIN EXCHANGE PROCEDURE. THE TARGET LESION WAS LOCATED IN THE BILIARY TUBE. A 035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED AND PLACED IN THE EXISTING TUBE, TUBE WAS REMOVED, AND A NEW TUBE WAS PLACED. PHYSICIAN NOTICED WIRE WAS UNRAVELING SO HE ADDED A NON- BOSTON SCIENTIFIC (BSC) WIRE TO AMPLATZ WIRE TO MAINTAIN ACCESS. THE PHYSICIAN REMOVED THE TUBE AND NO ISSUES WITH TUBE. THE PHYSICIAN THEN CAREFULLY REMOVED WIRE SUCCESSFULLY BUT WAS CONCERNED BECAUSE THE WIRE CONTINUED TO UNRAVEL DURING REMOVAL. HOWEVER, DURING THE PROCEDURE THE AMPLATZ WIRE SHEARED OFF IN THE BILIARY TUBE AND BECAME STUCK IN THE PATIENT'S DUODENUM. ALL COMPONENTS WERE SUCCESSFULLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT STATUS WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138485 ↗
• InjuryDec 20, 2022Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE COATING PEELED. AN AMPLATZ PI GUIDEWIRE WAS SELECTED FOR USE IN A BILIARY STENTING PROCEDURE. A BILIARY STENT WAS SUCCESSFULLY PLACED IN THE LEFT BILE DUCT. AFTER PLACEMENT OF THE STENT, THE AMPLATZ WAS REMOVED. DURING REMOVAL THE WIRE COATING PEELED FROM THE WIRE. SOME FRAGMENTS OF THE COATING COULD HAVE REMAINED ATTACHED TO THE IMPLANTED BILIARY STENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICES. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 16014107 ↗
• MalfunctionDec 12, 2022Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23-NOV-2022. IT WAS REPORTED THAT DIFFICULTY TRACKING OVER WIRE WAS ENCOUNTERED. THE PATIENT PRESENTED WITH KIDNEY STONE. THE STENOSED TARGET LESION WAS LOCATED IN THE NON-CALCIFIED AND NON-TORTUOUS KIDNEY. A 035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING THE PROCEDURE, IT DID NOT ALLOW THE STENT TO PASS OVER THE WIRE. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A NON-BSC GUIDEWIRE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE CORE WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15960677 ↗
• MalfunctionOct 11, 2022Entrapment of Device; Fracture; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE GUIDEWIRE BECAME ENTRAPPED IN THE BILIARY STENT AND FRACTURED. AN AMPLATZ S/S ST/035/145 (BX/1) SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE WITH A BILIARY STENT. THE GUIDEWIRE BECAME ENTRAPPED IN THE BILIARY STENT AND HAD FRACTURED INTO TWO PARTS, THE STRUCTURE AND THE ASSEMBLY. THE FRACTURE WAS NOTICED WHEN THE GUIDEWIRE WAS BEING REMOVED FROM THE PATIENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15583107 ↗
• InjuryAug 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT THIS GUIDEWIRE WAS NOT SUPPORTIVE DUE TO A BREAK IN THE CORE. THIS AMPLATZ GUIDEWIRE WAS SELECTED FOR USE TO ADVANCE THE CATHETER INTRODUCER. DURING INSERTION OF THE CATHETER INTRODUCER, THE GUIDEWIRE WAS NOT SUPPORTIVE OF THE LONG SLIDING PRESSURE FROM THE JUGULAR VEIN ENTRY TO THE EXTREME DISTAL END. UPON EXTRACTION, THERE WAS VISUAL BREAK OF THE INTERNAL CORE OF THE GUIDEWIRE. THE DEVICE WAS REMOVED FROM THE VASCULAR SITE AFTER MAIN SURGICAL ACCESS. IT WAS REPORTED THAT THE PATIENT CONSEQUENCE INVOLVED SURGERY AND HOSPITALIZATION. NO SPECIFIC PATIENT ADVERSE EVENTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259961 ↗
• InjuryAug 15, 2022Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED THAT A DETACHMENT OCCURRED REQUIRING SURGERY. THE MODERATELY STENOSED TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED AND MODERATELY TORTUOUS SUBCLAVIAN ARTERY. AN AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE IN A SUBCLAVIAN VEIN, RECANALIZATION PROCEDURE. WHILE INSERTING THE GUIDEWIRE INTO THE INTRODUCER SHEATH, THE GUIDEWIRE DID NOT ADVANCE. THE GUIDEWIRE UNSHEATHED AND DETACHED INSIDE THE PATIENT. SURGERY WAS REQUIRED TO REMOVE THE REMAINING PIECE OF THE GUIDEWIRE. THE PATIENT HOSPITALIZATION WAS PROLONGED AND THEIR STATUS IS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15225976 ↗
• InjuryJul 8, 2022Difficult to Remove; Unraveled Material; Difficult to Remove; Unraveled Material

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE OCCURRED. A 035/145 (BX/1) AMPLATZ SUPER STIFF WAS ADVANCED TO CROSS THE LESION. HOWEVER, DURING THE PROCEDURE THE WIRE CAME UNRAVELED AND IT WAS DIFFICULT TO GET IT OUT FROM THE PATIENT. A NON-BOSTON SCIENTIFIC STENT WAS PLACED AND PULLED THE DEVICE WITH IT WITH NOTHING LEFT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958505 ↗
• MalfunctionMar 8, 2022Entrapment of Device; Unraveled Material; Entrapment of Device; Unraveled Material

  IT WAS REPORTED THAT THE GUIDEWIRE BECAME ENTRAPPED. A 035/145 AMPLATZ SUPER STIFF GUIDEWIRE WAS SELECTED FOR USE. DURING AN EXCHANGE OF OF A NON-BSC NEPHROSTOMY TUBE, THE AMPLATZ GUIDEWIRE BECAME ENTRAPPED. UPON REMOVAL OF BOTH THE NEPHROSTOMY TUBE AND AMPLATZ, THE DISTAL END OF THE AMPLATZ HAD UNRAVELED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13696517 ↗
• MalfunctionFeb 16, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A SEPARATION OCCURRED. FOUR AMPLATZ SUPER STIFF GUIDEWIRES WERE SELECTED FOR USE. THE GUIDEWIRES KEPT SEPARATING FROM THEIR CORE WHEN LOADING THE CATHETER OVER THE GUIDEWIRES. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13546311 ↗