Python® Embolectomy Catheter A4E02Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915113414), received between Mar 6, 2017 and Oct 13, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2017Deflation Problem; Deflation Problem

  INCIDENT DESCRIPTION: "PLEASE SEE THE ATTACHED REPORT 'AMR2017-23' WITH PICTURE. EVENT DESCRIPTION: ON (B)(6) 2017: DURING A PREPARATION A MEDICAL STAFF TRIED TO INFLATE AND DEFLATE THE BALLOON BEFORE INSERTING INTO THE PATIENT'S VESSEL. THEN THE MEDICAL STAFF FOUND THAT THE BALLOON DIDN'T DEFLATE PROPERLY. THUS, THE MEDICAL STAFF ELECTED TO USE ANOTHER PYTHON CATHETER FOR THE SURGERY. THE SECOND CATHETER DEFLATED PROPERLY AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM. THIS EVENT DIDN'T AFFECT THE PATIENT. COMMENTS FROM COSMOTEC:: COMPLAINT SAMPLE WAS RETURNED FROM THE HOSPITAL. THE SAMPLE WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. INVESTIGATION REPORT IS REQUIRED FOR THIS CASE. ON (B)(6), WE TRIED TO VALIDATE THE ISSUE. WE TRIED TO INFLATE AND DEFLATE THE BALLOON SEVERAL TIMES, THEN WE COULD DUPLICATE THE ISSUE SOMETIMES. DID THE ISSUE HAPPEN OFTEN WITH PYTHON CATHETER BECAUSE THE PYTHON HAS DOUBLE LUMEN? OR THIS ISSUE HAPPENED ONLY FOR THIS PRODUCT?" TYPE OF INTERVENTION: "THE MEDICAL STAFF ELECTED TO USE ANOTHER PYTHON CATHETER FOR THE SURGERY. THE SECOND CATHETER DEFLATED PROPERLY AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEM." PATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950151 ↗
• MalfunctionMar 6, 2017Burst Container or Vessel; Burst Container or Vessel

  REMOVING BLOOD CLOTS - "(DURING A CLINICAL USE ON (B)(6) 2015) THE CATHETER WAS USED TO REMOVE BLOOD CLOTS IN A BYPASS VESSEL AT BELOW KNEE. THERE WAS NO PROBLEM WITH THE BALLOON WHEN IT WAS CHECKED BEFORE USE, HOWEVER; THE BALLOON RUPTURED WHEN IT WAS INFLATED IN PATIENT'S BLOOD VESSEL. THE AMOUNT OF SALINE WAS GOOD. PERHAPS THE CALCIFIED VESSEL CAUSED THE RUPTURE. ONE OF THE ABOVE LOTS WAS CONSIDERED BASED ON THE SHIPPING HISTORY. (B)(4)." PATIENT STATUS - "NO PATIENT INJURY."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382145 ↗