Python® Embolectomy Catheter A4E04Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00607915113438), received between Aug 17, 2016 and May 31, 2018 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

• MalfunctionMay 31, 2018Break; Break

  PROCEDURE PERFORMED: "THROMBECTOMY" "PLEASE SEE THE ATTACHED REPORT (B)(4) WITH PICTURES. ON (B)(6) 2018: DURING A PROCEDURE [PROCEDURE: THROMBECTOMY] THE PYTHON CATHETER A4E04 WAS INSERTED INTO A PATIENT'S VESSEL. WHEN A MEDICAL STAFF TRIED TO INFLATE THE BALLOON IN THE PATIENT'S VESSEL, THE STAFF REALIZED THAT THE INFLATION TUBE WAS BROKEN. THE MEDICAL STAFF ELECTED TO REMOVE THE PYTHON CATHETER FROM THE PATIENT'S VESSEL AND USE ANOTHER PYTHON CATHETER FOR THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THIS EVENT DIDN'T AFFECT THE PATIENT. COMMENTS FROM COSMOTEC: WE CONFIRMED THE DEFECTIVE POINT WHERE THE CONNECTION AREA BETWEEN INFLATION TUBE AND GUIDEWIRE HUB. IT'S NOT SURE THAT USER PERFORMED PRIOR CHECKING (INSPECTION) OR NOT FOR THE COMPLAINT SAMPLE. THE USER IS HEAVY USER OF PYTHON CATHETER FOR A LONG TIME AND THE USER IS FAMILIAR WITH USING PYTHON CATHETER. INVESTIGATION REPORT FOR THIS CASE IS REQUIRED. THE INFLATION TUBE IS BROKEN." TYPE OF INTERVENTION: "THE MEDICAL STAFF ELECTED TO REMOVE THE PYTHON CATHETER FROM THE PATIENT'S VESSEL AND USE ANOTHER PYTHON CATHETER FOR THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM." PATIENT STATUS: "THIS EVENT DID

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7559169 ↗
• MalfunctionDec 5, 2017Material Rupture; Material Rupture

  PROCEDURE PERFORMED: "EMERGENCY THROMBECTOMY". INCIDENT DESCRIPTION: CER 1 OF 3: (B)(4), CER 2 OF 3:(B)(4), CER 3 OF 3: (B)(4). "PLEASE SEE THE ATTACHED REPORT ' (B)(4) '. NO COMPLAINT SAMPLE WAS RETURNED FROM HOSPITAL, BUT COSMOTEC WOULD LIKE APPLIED MEDICAL TO ISSUE ONE (1) PYTHON CATHETER CREDIT MEMO FOR THIS CASE. (ON (B)(6) 2017: DURING A PROCEDURE) AN EMERGENCY THROMBECTOMY WAS PERFORMED. THE PHYSICIAN SUSPECTED THAT THROMBUS/THROMBI ARE SCLEROSED. THE PHYSICIAN PREPARED THREE (3) PYTHON CATHETERS FOR THE PROCEDURE. ALL THREE OF THE PYTHON CATHETERS WERE RUPTURED WHEN THE PHYSICIAN TRIED TO REMOVE THE THROMBUS/THROMBI FROM A BLOOD VESSEL. THE PHYSICIAN ELECTED TO USE ANOTHER CATHETER FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED BY EMAIL AT 10:32 PM ON (B)(6) 2017 FROM (B)(6): THIS WAS NOT A ROBOTIC CASE. THE BALLOON DID NOT OCCLUDE THE VESSEL. THERE WAS NO DAMAGE TO THE VESSEL. DID THE CATHETER COME INTO CONTACT WITH ANY SHARP OBJECTS THROUGHOUT THE PROCEDURE? ACCORDING TO THE INFORMATION FROM THE CUSTOMER, THE PATIENT HAS THROMBUS/THROMBI CALCIFICATION. DID THE SURGEON HAVE ANY DIFFICULTY INSERTING OR REMOVING THE CATHETER? -WE COULDN'T GET THIS INFORMATION FROM THE SU

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085409 ↗
• MalfunctionDec 5, 2017Material Rupture; Material Rupture

  PROCEDURE PERFORMED: "EMERGENCY THROMBECTOMY" INCIDENT DESCRIPTION: CER 1 OF 3: (B)(4) CER 2 OF 3: (B)(4) CER 3 OF 3: (B)(4) NO COMPLAINT SAMPLE WAS RETURNED FROM HOSPITAL, BUT COSMOTEC WOULD LIKE APPLIED MEDICAL TO ISSUE ONE (1) PYTHON CATHETER CREDIT MEMO FOR THIS CASE. (ON (B)(6) 2017: DURING A PROCEDURE) AN EMERGENCY THROMBECTOMY WAS PERFORMED. THE PHYSICIAN SUSPECTED THAT THROMBUS/THROMBI ARE SCLEROSED. THE PHYSICIAN PREPARED THREE (3) PYTHON CATHETERS FOR THE PROCEDURE. ALL THREE OF THE PYTHON CATHETERS WERE RUPTURED WHEN THE PHYSICIAN TRIED TO REMOVE THE THROMBUS/THROMBI FROM A BLOOD VESSEL. THE PHYSICIAN ELECTED TO USE ANOTHER CATHETER FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED BY EMAIL AT 10:32 PM ON 14-NOV-2017 FROM REGULATORY AFFAIRS: THIS WAS NOT A ROBOTIC CASE. THE BALLOON DID NOT OCCLUDE THE VESSEL. THERE WAS NO DAMAGE TO THE VESSEL. DID THE CATHETER COME INTO CONTACT WITH ANY SHARP OBJECTS THROUGHOUT THE PROCEDURE? ACCORDING TO THE INFORMATION FROM THE CUSTOMER, THE PATIENT HAS THROMBUS/THROMBI CALCIFICATION. DID THE SURGEON HAVE ANY DIFFICULTY INSERTING OR REMOVING THE CATHETER? -WE COULDN'T GET THIS INFORMATION FROM THE SURGEON. THERE WASN'T ANY UNINTENDED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085405 ↗
• MalfunctionDec 5, 2017Material Rupture; Material Rupture

  PROCEDURE PERFORMED: "EMERGENCY THROMBECTOMY" (B)(4). NO COMPLAINT SAMPLE WAS RETURNED FROM HOSPITAL, BUT (B)(6) WOULD LIKE APPLIED MEDICAL TO ISSUE ONE (1) PYTHON CATHETER CREDIT MEMO FOR THIS CASE. (ON (B)(6) 2017: DURING A PROCEDURE) AN EMERGENCY THROMBECTOMY WAS PERFORMED. THE PHYSICIAN SUSPECTED THAT THROMBUS/THROMBI ARE SCLEROSED. THE PHYSICIAN PREPARED THREE (3) PYTHON CATHETERS FOR THE PROCEDURE. ALL THREE OF THE PYTHON CATHETERS WERE RUPTURED WHEN THE PHYSICIAN TRIED TO REMOVE THE THROMBUS/THROMBI FROM A BLOOD VESSEL. THE PHYSICIAN ELECTED TO USE ANOTHER CATHETER FOR THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED BY EMAIL AT 10:32 PM ON (B)(6) 2017 FROM REGULATORY AFFAIRS: THIS WAS NOT A ROBOTIC CASE. THE BALLOON DID NOT OCCLUDE THE VESSEL. THERE WAS NO DAMAGE TO THE VESSEL. DID THE CATHETER COME INTO CONTACT WITH ANY SHARP OBJECTS THROUGHOUT THE PROCEDURE? ACCORDING TO THE INFORMATION FROM THE CUSTOMER, THE PATIENT HAS THROMBUS/THROMBI CALCIFICATION. DID THE SURGEON HAVE ANY DIFFICULTY INSERTING OR REMOVING THE CATHETER? -WE COULDN'T GET THIS INFORMATION FROM THE SURGEON. THERE WASN'T ANY UNINTENDED MATERIAL LEFT IN THE PATIENT. COULD YOU PROVIDE THE REASON WHY THE THREE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7085401 ↗
• MalfunctionApr 24, 2017Unraveled Material; Unraveled Material

  PROCEDURE PERFORMED: THROMBECTOMY. "WHEN REMOVING THE PYTHON OVER THE WIRE, WE THOUGHT THE PYTHON TIP WAS UNRAVELING. PHYSICIAN ASK FOR ME TO CHECK FOR ANY MALFUNCTIONS. I NOTICED THE BALLOON HAD A HOLE AND IT WASN'T INFLATING." ADDITIONAL INFO RECEIVED: JUNE 15, 2016. BALLOON WAS INSPECTED PRIOR TO THE START OF THE PROCEDURE. NO UNRAVELING FOUND ON THIS CATHETER; ONLY HOLE IN BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6517232 ↗
• MalfunctionMar 6, 2017Connection Problem; Connection Problem

  THROMBECTOMY - "PYTHON WOULDN'T DEFLATE AND HOLE IN BALLOON." TYPE OF INTERVENTION - THROMBECTORY. PATIENT STATUS - STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6382157 ↗
• MalfunctionFeb 28, 2017Detachment Of Device Component; Detachment Of Device Component

  THROMBECTOMY - "WHILE PERFORMING A THROMBECTOMY PROCEDURE A PYTHON A4E04, LOT # 1276316 WAS PLACED ARTERIALLY OVER A WIRE. WIRE WAS THEN REMOVED TO PERFORM AN ARTERIOGRAM VIA THE PYTHON. WE IMAGED TO CHECK OUR PLACEMENT AND NOTICED THAT THE DISTAL TIP OF THE PYTHON WAS NOT ATTACHED TO THE SHAFT OF THE CATHETER. THE TIP MOVED TO THE DISTAL BIFURCATION OF THE ULNAR RADIAL ARTERY. [DOCTORS] WERE ABLE TO RETRIEVE THE TIP WITH A SNARE." PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6366504 ↗
• MalfunctionJan 12, 2017Break; Break

  PROCEDURE PERFORMED UNKNOWN - "HAVING PROBLEMS FEEDING TERUMO GLIDES THROUGH THE FOGERTY AND THE BALLOON END BROKE OFF IN A PATIENT'S ARTERY. IT WAS DESCRIBED THAT 4IN OF THE TIP BROKE OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP WITH A SNARE." PATIENT STATUS - NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6246237 ↗
• MalfunctionOct 27, 2016Break; Break

  THE RUPTURE/PINHOLES EVENTS OCCURRED FREQUENTLY LATELY IN (B)(6). (ON (B)(6) 2016: DURING A PROCEDURE) THROMBECTOMY - "A THROMBECTOMY FOR EXTERNAL ILIAC ARTERY AND COMMON ILIAC ARTERY WAS PERFORMED AND PYTHON CATHETER WAS USED FOR THE SURGERY. THE PYTHON CATHETER WAS RUPTURED AFTER THE CATHETER WAS USED FOR THE PROCEDURE A COUPLE OF TIMES. THEN, ANOTHER PACKAGE PYTHON CATHETER WAS OPENED AND USED FOR SURGERY. HOWEVER, THE SECOND CATHETER WAS RUPTURED ON FIRST-TIME USE. AFTER THAT, THIRD PYTHON CATHETER WAS OPENED AND USED FOR THE THROMBECTOMY FOR PERIPHERAL ARTERY. HOWEVER, THE THIRD CATHETER WAS ALSO RUPTURED ON THE FIRST-TIME USE. A MEDICAL STAFF ELECTED TO USE A FOGARTY CATHETER (EDWARDS LIFESCIENCES LLC) AND PROCEED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM." COMMENTS FROM DISTRIBUTOR: "ALTHOUGH NO COMPLAINT DEVICES WERE RETURNED FROM THE HOSPITAL, WE REPORT THIS CASE. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. " PATIENT STATUS - "NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON OCTOBER 6, 2016 FROM DISTRIBUTOR - ASKED TO CLARIFY WHAT WAS MEANT BY "CATHETER WAS RUPTURED" RUPTURED AND RECEIVED RESPONSE STATING THAT "I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6062440 ↗
• MalfunctionOct 27, 2016Break; Break

  THE RUPTURE/PINHOLES EVENTS OCCURRED FREQUENTLY LATELY IN (B)(6). (ON (B)(6) 2016: DURING A PROCEDURE) THROMBECTOMY - "A THROMBECTOMY FOR EXTERNAL ILIAC ARTERY AND COMMON ILIAC ARTERY WAS PERFORMED AND PYTHON CATHETER WAS USED FOR THE SURGERY. THE PYTHON CATHETER WAS RUPTURED AFTER THE CATHETER WAS USED FOR THE PROCEDURE A COUPLE OF TIMES. THEN, ANOTHER PACKAGE PYTHON CATHETER WAS OPENED AND USED FOR SURGERY. HOWEVER, THE SECOND CATHETER WAS RUPTURED ON FIRST-TIME USE. AFTER THAT, THIRD PYTHON CATHETER WAS OPENED AND USED FOR THE THROMBECTOMY FOR PERIPHERAL ARTERY. HOWEVER, THE THIRD CATHETER WAS ALSO RUPTURED ON THE FIRST-TIME USE. A MEDICAL STAFF ELECTED TO USE A FOGARTY CATHETER (EDWARDS LIFESCIENCES LLC) AND PROCEED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM." COMMENTS FROM DISTRIBUTOR: "ALTHOUGH NO COMPLAINT DEVICES WERE RETURNED FROM THE HOSPITAL, WE REPORT THIS CASE. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. " PATIENT STATUS - "NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON OCTOBER 6, 2016 FROM DISTRIBUTOR - ASKED TO CLARIFY WHAT WAS MEANT BY "CATHETER WAS RUPTURED" RUPTURED AND RECEIVED RESPONSE STATING THAT "I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6062408 ↗
• MalfunctionOct 27, 2016Break; Break

  (B)(4). THE RUPTURE/PINHOLES EVENTS OCCURRED FREQUENTLY LATELY IN (B)(6). " (ON (B)(6) 2016: DURING A PROCEDURE): THROMBECTOMY - "A THROMBECTOMY FOR EXTERNAL ILIAC ARTERY AND COMMON ILIAC ARTERY WAS PERFORMED AND PYTHON CATHETER WAS USED FOR THE SURGERY. THE PYTHON CATHETER WAS RUPTURED AFTER THE CATHETER WAS USED FOR THE PROCEDURE A COUPLE OF TIMES. THEN, ANOTHER PACKAGE PYTHON CATHETER WAS OPENED AND USED FOR SURGERY. HOWEVER, THE SECOND CATHETER WAS RUPTURED ON FIRST-TIME USE. AFTER THAT, THIRD PYTHON CATHETER WAS OPENED AND USED FOR THE THROMBECTOMY FOR PERIPHERAL ARTERY. HOWEVER, THE THIRD CATHETER WAS ALSO RUPTURED ON THE FIRST-TIME USE. A MEDICAL STAFF ELECTED TO USE A FOGARTY CATHETER (EDWARDS LIFESCIENCES LLC) AND PROCEED THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM." COMMENTS FROM (B)(4): "ALTHOUGH NO COMPLAINT DEVICES WERE RETURNED FROM THE HOSPITAL, WE REPORT THIS CASE. PLEASE INVESTIGATE THE POSSIBLE ROOT CAUSE. " PATIENT STATUS - "NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON OCTOBER 6, 2016 FROM (B)(6) - ASKED TO CLARIFY WHAT WAS MEANT BY "CATHETER WAS RUPTURED" RUPTURED AND RECEIVED RESPONSE STATING THAT "

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6061437 ↗
• MalfunctionAug 17, 2016Break; Break

  THROMBECTOMY - PROXIMAL TIP WHERE THE HUB IS, SNAPPED - "THE BLUE PORTION." X-RAY TECH WAS ABLE TO THREAD OVER THE WIRE AND WHEN THE DOCTOR TRIED TO INFLATE THE BALLOON, THE PROXIMAL END SNAPPED - EVERYTHING WAS FINE DURING PREP. NO UNINTENDED MATERIAL ENTERED PATIENT." PATIENT STATUS - "NO IMPACT TO PATIENT." TYPE OF INTERVENTION - "OPENED A SECOND UNIT. SECOND UNIT WORKED AS EXPECTED." ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM (B)(6) ON AUGUST 4, 2016 - NO EXCESSIVE FORCE FOR THIS INCIDENT, BUT CUSTOMER DID SAY THAT THERE HAVE BEEN / ARE TIMES WHEN THE CATHETER IS DIFFICULT TO THREAD. NO BLOCKAGE WHEN INSERTING THE GUIDE WIRE. NOTHING DIFFERENT NOTICED FOR THE 2ND UNIT. NO LOT NUMBER FOR THE 2ND UNIT. THEY DID NOT THREAD THE WIRE DURING PREP. THE CONTRAST SOLUTION IS 50% SALINE AND 50% OMNIPAQUE CONTRAST. THE GUIDEWIRE USED WAS TERUMO (GR3506, GS3506), NEWTON GUIDEWIRE, USUALLY .035 DIAMETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5883849 ↗