Python® Embolectomy Catheter A4E08Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00607915113476), received between Jan 19, 2016 and Aug 10, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2018Material Separation; Material Separation

  PROCEDURE PERFORMED: "EMBOLECTOMY". "WE CONTINUE RECEIVE THE COMPLAINT, THE BALLOON BROKEN, AND NOT FILL IN THE SUGGEST VOLUME. SOME OF THEM ARE FOUND BROKEN IN PRE-TEST, OTHERS BROKE DURING SURGERY PROCEDURE. INJECT VOLUME WITH BROKEN: 1.5CC. WE RECEIVE A SERIES OF COMPLAINT PYTHON A4E08 DEVICE. BALLOONS BROKE DURING PRE-TEST OR SURGERY PROCEDURE. USERS SAID THEY DIDN'T OVER INJECTION LIQUID OR GAS, AND THE BALLOONS BROKE BEFORE SUGGEST VOLUME." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM PRODUCT SPECIALIST ON THURSDAY 21JUN2018. REGARDING THE QUESTIONS, USERS USUALLY PRE-TEST THE BALLOON BY NORMAL SALINE OR GAS. AFTER PRE-TEST, BALLOON KEEP UNINFLATED UNTIL IT IS USED FOR THE PATIENT. IF A CATHETER WITH BALLOON BROKEN DURING PRE-TEST OR PROCEDURE AND WILL BE REPLACED BY A NEW ONE. ACCORDING TO THE REPORT FROM USERS, THEY DIDN'T MENTIONED VESSEL DAMAGE AND UNINTENDED MATERIAL LEFT IN THE PATIENT. WE WILL TRY TO GET MORE INFORMATION ABOUT THIS ISSUE. TYPE OF INTERVENTION: NA. PATIENT STATUS: NA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7773193 ↗
• MalfunctionMar 29, 2018Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED: "THROMBECTOMY" EVENT DESCRIPTION: THE PYTHON CATHETER A4E08 WAS INSPECTED PRIOR TO THE START OF THE PROCEDURE AND THE BALLOON WAS INFLATED SUCCESSFULLY. WHEN A MEDICAL STAFF TRIED TO INFLATE THE BALLOON IN THE PATIENT'S VESSEL, THE BALLOON WAS RUPTURED EASILY. THE MEDICAL STAFF ELECTED TO REMOVE THE PYTHON CATHETER FROM THE PATIENT'S VESSEL AND USE ANOTHER PYTHON CATHETER A4E06 FOR THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. *IT'S NOT SURE THAT THE PATIENT'S VESSEL WAS CALCIFIED OR NOT THIS EVENT DIDN'T AFFECT THE PATIENT. *THE CATHETER IS NOT DECONTAMINATED THE BALLOON IS BROKEN." TYPE OF INTERVENTION: "USE ANOTHER PYTHON CATHETER A4E06 FOR THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM." PATIENT STATUS: "THIS EVENT DIDN'T AFFECT THE PATIENT. NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382086 ↗
• MalfunctionMar 6, 2017Break; Break

  PROCEDURE PERFORMED UNKNOWN -"FROM (B)(6), WE CONTINUE TO RECEIVE THE COMPLAINT, IN THE TEXT PROGRESS, THE BALLOON BROKEN, AND NOT FILL IN THE SUGGEST VOLUME, AND SOME IN THE SURGERY PROGRESS, NOT ARRIVE THE LISION THE BALLOON ALREADY BROKEN." PATIENT STATUS - "FINE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382149 ↗
• MalfunctionMar 6, 2017Break; Break

  PROCEDURE PERFORMED UNKNOWN - "FROM (B)(6), WE CONTINUE RECEIVE THE COMPLAINT, IN THE TEXT PROGRESS, THE BALLOON BROKEN, AND NOT FILL IN THE SUGGEST VOLUME, AND SOME IN THE SURGERY PROGRESS, NOT ARRIVED THE LISION THE BALLOON ALREADY BROKEN." PATIENT STATUS - "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382148 ↗
• MalfunctionJun 25, 2016Material Puncture/Hole; Material Puncture/Hole

  (B)(4). PROCEDURE PERFORMED: TVER. EMBOLIZATION WAS FOUND IN THE LEFT SUBCLAVIAN VESSEL OF THE PATIENT. IN ORDER TO COIL AT THE SITE OF EMBOLIZATION, THE PHYSICIAN USED PYTHON AS A SHEATH. DURING THIS, THE GUIDE WIRE POPPED OUT FROM THE PYTHON SHAFT BODY. ANOTHER PYTHON WAS OPENED AND USED FOR THE SECOND TRY. THE SECOND PYTHON WORKED WELL. THE OPERATION WAS SUCCESSFULLY COMPLETED. COMMENTS FROM COSMOTEC - "ONE (1) UNIT OF PYTHON CATHETER WAS RETURNED FROM THE CUSTOMER. WE CONFIRMED THE DEVICE AND FOUND THAT THERE WAS A HOLE ON THE CATHETER SHAFT, NEAR THE BLACK SINGLE MARKER AT THE DISTAL SIDE. THE SAMPLE IS AVAILABLE FOR AN INVESTIGATION. IT CAN BE RETURNED TO APPLIED MEDICAL." PATIENT STATUS: THERE WAS NO IMPACT TO THE OPERATION. NO HEALTH DAMAGE HAS BEEN REPORTED WITH THE PATIENT. ADDITIONAL INFORMATION RECEIVED: JUNE 17, 2016. WAS THE GUIDE WIRE BEING INSERTED OR REMOVED WHEN THE GUIDE WIRE POPPED OUT? WHEN THE GUIDE WIRE POPPED OUT, BOTH THE CATHETER AND THE GUIDE WIRE WAS REMOVED FROM THE PATIENT VESSEL. THE CUSTOMER OPENED NEW CATHETER AND CONTINUED THE OPERATION. WHAT GUIDE WIRE WAS BEING USED WITH THIS CATHETER? THE CUSTOMER USED RADIFOCUS GUIDEWIRE, ANGLED TYPE, MADE BY T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5749452 ↗
• MalfunctionJan 22, 2016Unraveled Material; Unraveled Material

  PAOD - "FROM (B)(6), WE CONTINUE GET THE COMPLIANT ABOUT A4E08, THE BALLOON BROKEN OR SOMETHING (NOT SURE WHAT IS IT, VERY LIKE SILK?) SHEDDING FROM THE CATHETER." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5386920 ↗
• MalfunctionJan 22, 2016Unraveled Material; Unraveled Material

  PAOD - "FROM NOVEMBER, WE CONTINUE GET THE COMPLIANT ABOUT A4E08, THE BALLOON BROKEN OR SOMETHING (NOT SURE WHAT IS IT, VERY LIKE SILK?) SHEDDING FROM THE CATHETER." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5386915 ↗
• MalfunctionJan 22, 2016Unraveled Material; Unraveled Material

  PAOD - "FROM (B)(6), WE CONTINUE GET THE COMPLIANT ABOUT A4E08, THE BALLOON BROKEN OR SOMETHING (NOT SURE WHAT IS IT, VERY LIKE SILK?) SHEDDING FROM THE CATHETER." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5386892 ↗
• MalfunctionJan 22, 2016Unraveled Material; Unraveled Material

  PAOD - "FROM (B)(6), WE CONTINUE GET THE COMPLIANT ABOUT A4E08, THE BALLOON BROKEN OR SOMETHING (NOT SURE WHAT IS IT, VERY LIKE SILK?) SHEDDING FROM THE CATHETER." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5386875 ↗
• MalfunctionJan 22, 2016Unraveled Material; Unraveled Material

  (B)(4) - "FROM NOVEMBER, WE CONTINUE GET THE COMPLIANT ABOUT A4E08, THE BALLOON BROKEN OR SOMETHING (NOT SURE WHAT IS IT, VERY LIKE SILK?) SHEDDING FROM THE CATHETER." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5386870 ↗
• MalfunctionJan 22, 2016Unraveled Material; Unraveled Material

  PAOD - "FROM (B)(6), WE CONTINUE GET THE COMPLAINT ABOUT A4E08, THE BALLOON BROKEN OR SOMETHING (NOT SURE WHAT IS IT, VERY LIKE SILK?) SHEDDING FROM THE CATHETER." PATIENT STATUS - OK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5386779 ↗
• MalfunctionJan 19, 2016Unraveled Material; Unraveled Material

  ADDITIONAL INFORMATION FROM THE DISTRIBUTOR WAS RECEIVED VIA E-MAIL ON MARCH 23, 2016: ALL THE RETURNED UNITS WERE FROM THE SAME HOSPITAL. THE UNITS WERE USED ON DIFFERENT PATIENTS, AND BY DIFFERENT DOCTORS. THE BALLOONS WERE INSPECTED OR TESTED BY INFLATION BEFORE BEING INSERTED IN THE PATIENT. THE PRODUCTS WERE INFLATED WITH A SALINE SOLUTION TO THE VOLUME SPECIFIED IN THE INSTRUCTIONS FOR USE (IFU). THE RETURNED UNITS WERE USED THROUGH A 6F INTRODUCER SHEATH. THE VESSEL'S CONDITION WAS DESCRIBED AS "STENOSIS." ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON MAY 31, 2016: "THIS HOSPITAL IS NOT A NEW ACCOUNT AND DON'T USE NEW TECHNIQUE."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5378484 ↗