Occlutech Delivery Set III 98DS009Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00885672010270), received between Dec 14, 2022 and Apr 20, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Fluid/Blood Leak; Air/Gas in Device

  REASON: AIR EMBOLUS IN DELIVERY SYSTEM NOTICED DURING IMPLANTATION OF PFO (OCCLUTECH IMPLANT) USING ODS III. POSSIBLE INCIDENCE OF VENTRICULAR ARRHYTHMIAS NOTED. PLEASE BE INFORMED OF THE NEW ODSIII COMPLAINT. CUSTOMER COMPLAINT WILL FOLLOW SOON. I WILL BE GLAD TO FORWARD YOUR ADDITIONAL QUESTIONS TO THE CUSTOMER. NOTIFICATION TO OCCLUTECH: 2ND APRIL, LOCATION: (B)(6), DATE: TO BE INVESTIGATED, PRODUCTS: ODS III AND PFO (PRODUCT CODES AND SERIAL NUMBERS BEING INVESTIGATED), DEVICES: PFO IMPLANTED AS PLANNED, NO FURTHER COMPLICATIONS. ODS III NOT RETRIEVED. "[?]" PATIENT: NO COMPLICATIONS REPORTED, ACTION: LOCAL AGENT WILL OBTAIN MORE CLINICAL INFORMATION.

  Patient problems: Air Embolism; Arrhythmia; Tachycardia

  MAUDE report 24931600 ↗
• MalfunctionJun 24, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  THE CUSTOMER REPORTED THAT DURING PATIENT CONTACT (DURING IMPLANTATION PROCESS) THE LOADER'S EXTREMITY DETACHED + SHEATH'S TIP WITH A LITTLE PLASTIC FRAGMENT FOUND DURING THE FLUSHING. I TOOK THE DEFECTIVE PRODUCTS (SHEATH WITH PLASTIC FRAGMENT + LOADER) TO SEND THEM FOR EXPERTISE. THE DEVICE WAS INSPECTED PRIOR TO USE; HOWEVER, IT'S NOTED THERE WAS A DEVIATION DURING THE INSPECTION. THERE WAS NO PRE-EXISTING CONDITION RELEVANT TO THE EVENT. PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO OTHER DEVICE USED TO COMPLETE THE PROCEDURE. THE CUSTOMER STATES THE REPORTED ISSUE WAS CLINICALLY SIGNIFICANT EXTENDED TREATMENT OR PROCEDURE TIME AND COULD HAVE BEEN VERY SERIOUS. THE DEVICE WILL BE RETURNED. 24/JUN/2025 CLARIFICATION OF EVENT RECEIVED: THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO OTHER DEVICE WAS USED BUT THE PATIENT WAS INVOLVED, SORRY FOR THE MISUNDERSTANDING. WE FOUND A LITTLE BLUE PLASTIC FRAGMENT PROVIDED FROM THE SHEATH DURING THE FLUSHING. YOU HAVE TO CONSIDER 2 DIFFERENT PROBLEMS: THE FIRST ONE WAS THE LITTLE PLASTIC FRAGMENT FROM THE SHEATH FOUND DURING THE FLUSHING, AND THE SECOND ONE WAS THE GLUING PROBLEM CONCERNING THE LOADER. FOR THE FIRST PROBLEM (BLUE PLASTIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22321745 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Difficult to Flush; Fluid/Blood Leak; Difficult to Flush

  THE CUSTOMER REPORTED THE TYPE OF PROCEDURE: PATENT FORAMEN OVALE (PFO) CLOSURE. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE. NO PICTURES OR VIDEO BUT IF YOU FLUSH THE LATERAL WAY OF THE SHEATH YOU WILL SEE EASILY THE LEAK THROUGH THE TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201894 ↗
• MalfunctionApr 21, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT WHEN INSTALLING THE CATHETER CARRYING THE PROBE, THE PROXIMAL PART OF THE VALVE BECOMES DETACHED (NON-BONDING). RISK OF AIR EMBOLISM GAS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873467 ↗
• MalfunctionDec 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE HEMOSTATIC VALVE OF THE ODS III SHEATH WAS LEAKING.THE DEVICE INFORMATION IS CURRENTLY UNAVAILABLE. ONCE THE DEVICE INFORMATION IS RECEIVED THE INFORMATION WILL BE PROVIDED. THE CUSTOMER REPORTED THE PROCEDURE WAS A FOP CLOSURE. ONE FOP DEVICE ("FOP" MEANS "PFO" PATENT FORAMEN OVALE) WAS INSERTED THROUGH THE SHEATH AT THE TIME OF THE EVENT. THERE WAS NO PATIENT IMPACT NOTED. THERE WAS A SLIGHT DELAY IN THE PROCEDURE BUT LESS THAN 30 MINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283402 ↗
• MalfunctionNov 11, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  THE EVENT OCCURRED PRIOR TO PATIENT CONTACT, DURING DEVICE PREPARATION BUT BEFORE DEVICE POSITIONING. WHILE RINSING LOADER, WITH PUSHER ALREADY INTRODUCED, TO PREPARE FOR PROCEDURE, THE RINSING SOLUTION IS SPRAYING OUT SIDEWAYS, BETWEEN SEAL AND FITTING OF THE VALVE, SINCE THE LOADER WASN'T OBVIOUSLY TIGHT. AFTER POSITIONING OCCLUDER (STILL ATTACHED TO THE PUSHER AND SHEATH CONNECTED TO THE LOADER) AN ANGIOGRAPHY SHOULD BE PERFORMED TO EVALUATE PLACEMENT. UNNECESSARILY, BUT BECAUSE USED TO IT, THE PHYSICIAN ASPIRATED AT THE SHEATH. IMMEDIATELY BUBBLES APPEARED IN THE HOSE TO THE STOPCOCK. IN THE VERY MOMENT, IT WASN'T SEEN A WAY TO GET RID OF THE BUBBLES AND WE DECIDED NOT TO DO AN ANGIOGRAPHY AND COMPLETE THE PROCEDURE WITHOUT IT. ONLY THE LOADER WAS REPLACED WITH ANOTHER LOADER FROM ANOTHER SET, WITH SAME MODEL AND SAME LOT NUMBER. WITH THE NEW LOADER, THE ISSUE WAS RESOLVED, AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO REPORTED PATIENT ADVERSE SIDE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18117026 ↗
• MalfunctionOct 17, 2023Air/Gas in Device; Air/Gas in Device

  THE CUSTOMER REPORTED DELIVERY SET AND LOADER ALONG OCCLUDER AND PUSHER WERE PREPARED. DELIVERY SET WAS INTRODUCED AND FORWARDED THROUGH THE DEFECT TO THE LEFT ATRIUM. BEFORE ATTACHING LOADER IT WAS REALIZED THAT THERE WERE SOME AIR BUBBLES IN IT. LOADER WAS RINSED AGAIN TO REMOVE BUBBLES AND ATTACHED WHILE RINSING. DURING IMPLANT PROCEDURE A T-WAVE UPLIFT IN ECG WAS FOUND. IMMEDIATELY VOLUME WAS ADDED AND AFTER 1-2 MINUTES ECG WAS NORMAL. OCCLUDER WAS IMPLANTED SUCCESSFULLY.

  Patient problems: Air Embolism; Non specific EKG/ECG Changes

  MAUDE report 17953366 ↗
• MalfunctionJul 12, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  WE RECEIVED THREE (3) NEW COMPLAINTS FROM FRANCE REGARDING THE ODSIII (3X 98DS009 / SN: (B)(6)). DURING 3 PROCEDURES THEY OBSERVED AN EKG ST+ ON EACH INDIVIDUAL PATIENT. IN EACH CASE, THE SAME ODSIII LOT IS AFFECTED. OUR SALES REP STATES THAT HE WAS PRESENT, AND THEY FOLLOWED THE CORRECT PROCEDURE FOR DE-AIRING BUBBLES IN THE SHEATH AND DURING LOADING OF THE PROSTHESIS. ADDITIONAL CASES REPORTED: 1035166-2023-00073 & 1035166-2023-00076. PROCEDURE FOR THE EVENT IS PFO CLOSURE AND AIR BUBBLES WERE OBSERVED DURING THE PROCEDURE. CUSTOMER REPORTED THE DEVICES INSERTED THROUGH THE SHEATH WERE FLEX II PFO OCCLUDER. ONE PER SHEATH/ PATIENT. CUSTOMER REPORTED MALE AND FEMALE PATIENTS INVOLVED IN THE 3 CASES. NO OTHER PATIENT IDENTIFICATION RECEIVED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305464 ↗
• MalfunctionJul 12, 2023Air/Gas in Device; Air/Gas in Device

  WE RECEIVED THREE (3) NEW COMPLAINTS FROM FRANCE REGARDING THE ODSIII (3X 98DS009 / SN: (B)(6). DURING 3 PROCEDURES THEY OBSERVED AN EKG ST ON EACH INDIVIDUAL PATIENT. IN EACH CASE, THE SAME ODSIII LOT IS AFFECTED. OUR SALES REP STATES THAT HE WAS PRESENT, AND THEY FOLLOWED THE CORRECT PROCEDURE FOR DE-AIRING BUBBLES IN THE SHEATH AND DURING LOADING OF THE PROSTHESIS. ADDITIONAL CASES REPORTED: 1035166-2023-00073 & 1035166-2023-00074. PROCEDURE FOR THE EVENT IS PFO CLOSURE AND AIR BUBBLES WERE OBSERVED DURING THE PROCEDURE. CUSTOMER REPORTED THE DEVICES INSERTED THROUGH THE SHEATH WERE FLEX II PFO OCCLUDER. ONE PER SHEATH/ PATIENT. CUSTOMER REPORTED MALE AND FEMALE PATIENTS INVOLVED IN THE 3 CASES. NO OTHER PATIENT IDENTIFICATION RECEIVED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305388 ↗
• MalfunctionJul 12, 2023Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  WE RECEIVED THREE (3) NEW COMPLAINTS FROM FRANCE REGARDING THE ODSIII (3X 98DS009 / SN:(B)(6). DURING 3 PROCEDURES THEY OBSERVED AN EKG ST+ ON EACH INDIVIDUAL PATIENT. IN EACH CASE, THE SAME ODSIII LOT IS AFFECTED. OUR SALES REP STATES THAT HE WAS PRESENT, AND THEY FOLLOWED THE CORRECT PROCEDURE FOR DE-AIRING BUBBLES IN THE SHEATH AND DURING LOADING OF THE PROSTHESIS. ADDITIONAL CASES REPORTED: 1035166-2023-00074 & 1035166-2023-00076 PROCEDURE FOR THE EVENT IS PFO CLOSURE AND AIR BUBBLES WERE OBSERVED DURING THE PROCEDURE. CUSTOMER REPORTED THE DEVICES INSERTED THROUGH THE SHEATH WERE FLEX II PFO OCCLUDER. ONE PER SHEATH/ PATIENT. CUSTOMER REPORTED MALE AND FEMALE PATIENTS INVOLVED IN THE 3 CASES. NO OTHER PATIENT IDENTIFICATION RECEIVED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17305223 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING TESTS OF THE NEW ODS ILL IN 3 HOSPITALS WITH A TOTAL OF 4 ODSIII THERE WAS A LEAKAGE AT THE HEMOSTATIC VALVE OF THE LOADER IN ALL 4 ODSIII, WHEN THEY WORKED WITH THE CONTRAST MEDIA PUMP (FLOW 15MUSEC; VOLUME 20ML). THEY TRIED TO HANDLE IT WITH LESS FLOW/MIN (FLOW 1 0MUMIN, VOLUME 15ML) WITH THE SAME RESULT: A CONTRAST MEDIUM JET SPRAYED OUT THROUGH THE HEMOSTATIC VALVE. AT LEAST A PART OF THE CONTRAST MEDIA ARRIVED AT THE TARGET TO VERIFY THE POSITION OF THE OCCLUDER. ALL THREE HOSPITALS DECIDED TO CONTINUE WITH THE OLDER ODS VERSION, AS THEY NEVER HAD THIS ISSUE WITH THE SCREW MECHANISM. THESE HOSPITALS PERFORM THERE PFO-CLOSURES ONLY WITH FLUOROSCOPY AND CONTRAST MEDIA AND TO HAVE A SAVE EVALUATION OF THE DEVICE POSITION, THEY ARE RELIANT TO THE CONTRAST MEDIA PUMP.THERE WAS NO HARM OF ANY PATIENT. THIS EVENT IS ADDRESSED UNDER (B)(4). SECOND EVENT IS ADDRESSED UNDER (B)(4). THIRD EVENT IS ADDRESSED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618573 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING TESTS OF THE NEW ODS ILL IN 3 HOSPITALS WITH A TOTAL OF 4 ODSIII THERE WAS A LEAKAGE AT THE HEMOSTATIC VALVE OF THE LOADER IN ALL 4 ODSIII, WHEN THEY WORKED WITH THE CONTRAST MEDIA PUMP (FLOW 15MUSEC; VOLUME 20ML). THEY TRIED TO HANDLE IT WITH LESS FLOW/MIN (FLOW 1 0MUMIN, VOLUME 15ML) WITH THE SAME RESULT - A CONTRAST MEDIUM JET SPRAYED OUT THROUGH THE HEMOSTATIC VALVE. AT LEAST A PART OF THE CONTRAST MEDIA ARRIVED AT THE TARGET TO VERIFY THE POSITION OF THE OCCLUDER. ALL THREE HOSPITALS DECIDED TO CONTINUE WITH THE OLDER ODS VERSION, AS THEY NEVER HAD THIS ISSUE WITH THE SCREW MECHANISM. THESE HOSPITALS PERFORM THERE PFO-CLOSURES ONLY WITH FLUOROSCOPY AND CONTRAST MEDIA AND TO HAVE A SAVE EVALUATION OF THE DEVICE POSITION, THEY ARE RELIANT TO THE CONTRAST MEDIA PUMP.THERE WAS NO HARM OF ANY PATIENT. THIS EVENT IS ADDRESSED UNDER (B)(4). SECOND EVENT IS ADDRESSED UNDER (B)(4). THIRD EVENT IS ADDRESSED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618555 ↗
• MalfunctionMar 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  FIRST IMPLANTATION WITH NEW ODSIII. AFTER PRODUCT PRESENTATION AND TRAINING. REGULAR PFO PROCEDURE. PROBING OF THE DEFECT, INSERTION OF AN OCCLUTECH GUIDEWIRE INTO THE LUPV. AFTER PREPARING THE ODSIII (FLUSHING, CONNECTING) AND PREPARING THE REQUIRED OCCLUDER (19PFO25D). ODS WAS BROUGHT FORWARD INTO THE LA WITHOUT ANY PROBLEMS, AFTER REMOVAL OF WIRE AND DILATOR AND DEAIRING BY ASPIRATION, HEPARIN WAS GIVEN. THE PREPARED OCCLUDER IN THE LOADER WAS CONNECTED TO THE ODS UNDER MANUAL FLUSHING. NOW ASPIRATION AT THE SIDE PORT OF THE ODS AND AIR ENTRY AT THE HEMOSTATIC VALVE OF THE LOADER. LOADER WAS REMOVED FROM THE ODS AND AIR WAS ASPIRATED FROM THE SIDE PORT OF ODS. NOW COMPLICATION-FREE IMPLANTATION OF THE OCCLUDER. POSITION CONTROL WITH X-RAY AND TTE, FINAL KM INJECTION SHOWS A LEAKING HEMOSTATIC MEMBRANE ON THE ODS (KM SPLASHED OUT). IN GOOD LOCATION, DETACHMENT OF THE OCCLUDER AND TERMINATION OF THE PROCEDURE WITHOUT PATIENT DAMAGE AND VERY GOOD RESULT. THE PATIENT LEFT THE CATH LAB IN GOOD CONDITION. NO PATIENT INJURY OR CONSEQUENCES REPORTED. DEFECT SIZE ABOUT 11MM: TEE MEASUREMENT. THIS EVENT IS ADDRESSED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618219 ↗
• MalfunctionMar 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  FIRST IMPLANTATION WITH NEW OCCLUTECH DELIVERY SET III (ODSIII). AFTER PRODUCT PRESENTATION AND TRAINING. REGULAR PFO PROCEDURE. PROBING OF THE DEFECT, INSERTION OF AN OCCLUTECH GUIDEWIRE INTO THE LUPV. AFTER PREPARING THE ODSIII (FLUSHING, CONNECTING) AND PREPARING THE REQUIRED OCCLUDER (19PFO25D). ODS WAS BROUGHT FORWARD INTO THE LA WITHOUT ANY PROBLEMS, AFTER REMOVAL OF WIRE AND DILATOR AND DE-AIRING BY ASPIRATION, HEPARIN WAS GIVEN. THE PREPARED OCCLUDER IN THE LOADER WAS CONNECTED TO THE ODS UNDER MANUAL FLUSHING. NOW ASPIRATION AT THE SIDE PORT OF THE ODS AND AIR ENTRY AT THE HEMOSTATIC VALVE OF THE LOADER. LOADER WAS REMOVED FROM THE ODS AND AIR WAS ASPIRATED FROM THE SIDE PORT OF ODS. NOW COMPLICATION-FREE IMPLANTATION OF THE OCCLUDER. POSITION CONTROL WITH X-RAY AND TTE, FINAL KM INJECTION SHOWS A LEAKING HEMOSTATIC MEMBRANE ON THE ODS (KM SPLASHED OUT). IN GOOD LOCATION, DETACHMENT OF THE OCCLUDER AND TERMINATION OF THE PROCEDURE WITHOUT PATIENT DAMAGE AND VERY GOOD RESULT. THE PATIENT LEFT THE CATH LAB IN GOOD CONDITION. NO PATIENT INJURY OR CONSEQUENCES REPORTED. THIS EVENT IS ADDRESSED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526352 ↗
• MalfunctionMar 10, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING TESTS OF THE NEW OCCLUTECH DELIVERY SET III (ODS LLL) IN 3 HOSPITALS WITH A TOTAL OF 4 ODS III THERE WAS A LEAKAGE AT THE HEMOSTATIC VALVE OF THE LOADER IN ALL 4 ODS III, WHEN THEY WORKED WITH THE CONTRAST MEDIA PUMP (FLOW 15MUSEC; VOLUME 20ML). THEY TRIED TO HANDLE IT WITH LESS FLOW/MIN (FLOW 1 0MUMIN, VOLUME 15ML) WITH THE SAME RESULT - A CONTRAST MEDIUM JET SPRAYED OUT THROUGH THE HEMOSTATIC VALVE. AT LEAST A PART OF THE CONTRAST MEDIA ARRIVED AT THE TARGET TO VERIFY THE POSITION OF THE OCCLUDER. ALL THREE HOSPITALS DECIDED TO CONTINUE WITH THE OLDER ODS VERSION, AS THEY NEVER HAD THIS ISSUE WITH THE SCREW MECHANISM. THESE HOSPITALS PERFORM THERE PFO-CLOSURES ONLY WITH FLUOROSCOPY AND CONTRAST MEDIA, AND TO HAVE A SAVE EVALUATION OF THE DEVICE POSITION, THEY ARE RELIANT TO THE CONTRAST MEDIA PUMP. THERE WAS NO PATIENT CONSEQUENCES OR HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, USING THE SAME ODS LLL DEVICE. THE DEVICE WAS DISCARDED BY THE HOSPITAL. THIS EVENT IS ADDRESSED UNDER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526221 ↗
• MalfunctionFeb 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  DURING PROCEDURE ODS III WITH THE ACIST CONTRAST DELIVERY SYSTEM, THE HEMOSTATIC VALVES ARE LEAKING. WITH HIS STANDARD SETTINGS THE LEAK WAS BIG AND WAS NOT BETTER WITH THE REDUCED SETTINGS. THERE WAS NO PATIENT SIDE EFFECTS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397053 ↗
• MalfunctionJan 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THIS OCCLUTECH DELIVERY SET III (ODS III) WAS USED IN SUPPORT OF PATENT FORAMEN OVALE (PFO) CASE. THIS IS THE FIRST TIME THIS PHYSICIAN HAS USED THE OCCLUDER (ODS III). THE MATERIAL WAS INSPECTED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. THEY PLACED THE OCCLUDER IN THE RIGHT POSITION, EVERYTHING LOOKED PERFECT, OCCLUDER WAS STILL CONNECTED TO THE PISTOL PUSHER, AND READY FOR THE CONTROL FLUOROSCOPY. BEFORE THEY ADMINISTERED CONTRAST MEDIA, THEY WANTED TO ASPIRE BLOOD FROM THE SHEATH SIDEPORT, THEY COULD ONLY ASPIRE AIR FROM THE CONNECTION SHEATH LOADER VALVE. IT WAS CONFIRMED THE SCREW MECHANISM WAS CONNECTED CORRECTLY, SO THEY TRIED TO ASPIRE BLOOD FROM THE LOADER SIDEPORT WITH NO SUCCESS. THEY DECIDED TO DISCONNECT THE LOADER FROM THE SHEATH, ONCE DISCONNECTED THEY COULD ASPIRE BLOOD. HOWEVER, WHEN THEY ADMINISTERED CONTRAST MEDIA, THE HEMOSTATIC VALVE WAS LEAKING. THE INTERVENTION WAS PERFORMED TO THE END WITHOUT ANY HARM TO THE PATIENT AND WITHOUT ANY PROCEDURE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME ODS III DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223846 ↗
• MalfunctionDec 14, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT PATIENT OBSERVED ST ELEVATION IN ECG WHILE OCCLUTECH DELIVERY SET III(ODS) WAS PLACED IN LA. PHYSICIAN ADVANCED THE ODS INTO THE RA - TO PREVENT MORE BUBBLES FROM GETTING INTO THE LEFT/ARTERIAL CIRCUIT - AND THEY INCREASED THE O2-LEVEL INSTANTLY TO 100%. IN LESS THAN A MINUTE ST ELEVATION WAS GONE, AND EVERYTHING WAS FINE WITH THE PATIENT. NEW ODS WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15980947 ↗