Python® Embolectomy Catheter A4E05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00607915113445), received between Jan 17, 2017 and Apr 12, 2019 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2019Material Separation; Material Separation

  PROCEDURE PERFORMED: EMBOLECTOMY. THE CATHETER BROKE DURING TREATMENT. THE DOCTOR DIDN'T FEEL A LOT OF RESISTANCE WHEN REMOVING CATHETER. PLEASE REFER TO ENCLOSE FOR PICTURES AND VIDEOS FOR THIS EVENT. PATIENT STATUS: NO PATIENT INJURY. TYPE OF INTERVENTION: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8511922 ↗
• MalfunctionMar 23, 2018Burst Container or Vessel; Burst Container or Vessel

  PROCEDURE PERFORMED: "THROMBECTOMY" ANOTHER PYTHON CATHETER (LOT#1181977) WAS RETURNED FROM HOSPITAL BECAUSE THE CUSTOMER SUSPECTED THE BALLOON QUALITY DEFECT. WE ALSO WILL RETURN THE CATHETER TO APPLIED MEDICAL, SO PLEASE INVESTIGATE IT TOO." EVENT DESCRIPTION: ON (B)(6) 2017: DURING A PROCEDURE [PROCEDURE: THROMBECTOMY] WHEN MEDICAL STAFF TRIED TO REMOVE THROMBUS, THE BALLOON WAS RAPTURED. THE MEDICAL STAFF ELECTED TO REMOVE THE PYTHON CATHETER FROM THE PATIENT'S VESSEL AND USE COMPETITOR'S CATHETER FOR THE SURGERY. THIS EVENT DIDN'T AFFECT THE PATIENT." TYPE OF INTERVENTION:"THE MEDICAL STAFF ELECTED TO REMOVE THE PYTHON CATHETER FROM THE PATIENT'S VESSEL AND USE COMPETITOR'S CATHETER FOR THE SURGERY." PATIENT STATUS: "NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7366046 ↗
• MalfunctionMar 7, 2018Detachment Of Device Component; Detachment Of Device Component

  PROCEDURE PERFORMED: EMBOLECTOMY. EVENT DESCRIPTION: "OUR CUSTOMER COMPLAINED TO US FOR A PYTHON A4E05 DEVICE. THE DEVICE BROKE TO TWO PIECES DURING WITHDRAWING." "THE CATHETER BROKE DURING WITHDRAWING." THREE PHOTOGRAPHS ARE PROVIDED. THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 08FEB2018 FROM PRODUCT SPECIALIST FROM (B)(4), DISTRIBUTOR. THE DATE APPLIED MEDICAL WAS MADE AWARE OF THE EVENT WAS 06FEB2018. THE DATE APPLIED CONTACTED ON THE CER FORM OF 20DEC2017 WAS THE DATE THE HOSPITAL CONTACTED THE DISTRIBUTOR. "I MISUNDERSTOOD THE DATE AS WHEN THE HOSPITAL CONTACT US." TYPE OF INTERVENTION: NA. PATIENT STATUS: "NO INJURY"

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322512 ↗
• MalfunctionJan 10, 2018Material Rupture; Material Rupture

  PROCEDURE PERFORMED: "THROMBECTOMY." EVENT DESCRIPTION: "PLEASE SEE REPORT '(B)(4)' . WHEN MEDICAL STAFF TRIED TO REMOVE THROMBUS, THE BALLOON WAS RUPTURED. THE MEDICAL STAFF ELECTED TO REMOVE THE PYTHON CATHETER FROM THE PATIENT'S VESSEL AND USE COMPETITOR'S CATHETER FOR THE SURGERY. THIS EVENT DIDN'T AFFECT THE PATIENT." "COMPLAINT SAMPLE WAS DISCARDED IN THE HOSPITAL BECAUSE THE PATIENT HAS INFECTION. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION." ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL FROM REGULATORY AFFAIRS AND QUALITY ASSURANCE, ON TUESDAY 19-DEC-2017 "ACCORDING TO THE SALES REP., THE BALLOON RUPTURE ISSUE IS THE SAME AS (B)(6)." TYPE OF INTERVENTION: "USE COMPETITOR'S CATHETER FOR THE SURGERY" PATIENT STATUS: "THIS EVENT DIDN'T AFFECT THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7181236 ↗
• MalfunctionDec 6, 2017Material Rupture; Material Rupture

  PROCEDURE PERFORMED: THROMBECTOMY. INCIDENT DESCRIPTION: "PLEASE SEE REPORT (B)(6) WITH PICTURE." "WHEN MEDICAL STAFF TRIED TO REMOVE THROMBUS, THE BALLOON WAS RUPTURED. THE MEDICAL STAFF ELECTED TO REMOVE THE PYTHON CATHETER FROM THE PATIENT'S VESSEL AND USE COMPETITOR'S CATHETER FOR THE SURGERY. THIS EVENT DIDN'T EFFECT THE PATIENT." TYPE OF INTERVENTION: UNKNOWN. PATIENT STATUS: THIS EVENT DIDN'T EFFECT THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7087298 ↗
• MalfunctionJan 18, 2017Break; Break

  "(B)(4)." "(ON (B)(6) 2016: DURING A SURGERY) THE COMPLAINT CATHETER WAS USED FOR A THROMBECTOMY OPERATION FOR AN ARTIFICIAL BLOOD VESSEL. A MEDICAL STAFF INSPECTED THE CATHETER PRIOR TO USE AND NO PROBLEM WAS FOUND. THE CATHETER WAS INSERTED INTO A PATIENT VESSEL TO THE PROPER POSITION. THEN THE CATHETER WAS INFLATED, THE CATHETER BALLOON RUPTURED. THIS EVENT DIDN'T AFFECT THE PATIENT. HOWEVER, THE MEDICAL STAFF CONCERNS THE POSSIBILITY THAT PIECES OF CATHETER BALLOON WERE LEFT INSIDE THE PATIENT BODY OR NOT." "COMMENTS FROM (B)(4): ONE (1) UNIT OF CATHETER WAS RETURNED FROM THE HOSPITAL. WE CONFIRMED THE DEVICE AND FOUND THAT THERE WAS A SLIT ON THE CATHETER BALLOON. THE SAMPLE WILL BE RETURNED TO APPLIED MEDICAL. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE AND POSSIBILITY OF THE RESIDUAL PIECES OF CATHETER BALLOON LEFT IN THE PATIENT OR NOT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6262240 ↗
• MalfunctionJan 17, 2017Break; Break

  THROMBECTOMY-"(B)(4). THE RUPTURE/PINHOLES EVENTS OCCURRED FREQUENTLY LATELY IN (B)(6)." "(ON (B)(6) 2017: DURING A PROCEDURE) A THROMBECTOMY WAS PERFORMED A PYTHON CATHETER WAS USED FOR THE SURGERY. THE PYTHON CATHETER WAS RUPTURED WHEN A MEDICAL STAFF TRIED TO REMOVE A THROMBUS FROM A BLOOD VESSEL. NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT. NOTE: THE PYTHON CATHETER WAS NOT USED FOR ARTIFICIAL BLOOD VESSEL." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM DISTRIBUTOR ON JANUARY 17, 2017 - CERS HAVE ALREADY BEEN SUBMITTED FOR OTHER EVENTS. IT WAS ASKED IF BALLOON BURSTED/RUPTURED OR IF THE BALLOON LEAKED AS A RESULT OF A HOLE IN THE BALLOON. THE RESPONSE WAS THAT MEDICAL STAFF PERFORMED PRE-OPERATION CHECK AND NO PINHOLE WAS CONFIRMED AT THAT TIME. THE BALLOON DID NOT OCCLUDE THE VESSEL. THERE WAS NO DAMAGE TO THE VESSEL. THE CATHETER DID NOT COME INTO CONTACT WITH ANY SHARP OBJECTS THROUGHOUT THE PROCEDURE. PATIENT STATUS- "NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6258963 ↗