Python Embolectomy CatheterRecalls & reported problems across all models
Applied Medical Resources Corporation · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 6 models of Python Embolectomy Catheter by Applied Medical Resources Corporation in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2016 and Apr 12, 2019 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Break” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported Python Embolectomy Catheter problems
Device problems
- Break10
- Unraveled Material8
- Burst Container or Vessel5
- Material Rupture5
- Detachment Of Device Component2
- Material Separation2
- Adverse Event Without Identified Device or Use Problem1
- Connection Problem1
Patient problems
- No Consequences Or Impact To Patient35
- No Known Impact Or Consequence To Patient1
Python Embolectomy Catheter models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Python® Embolectomy Catheter A4E04Catheter, Embolectomy12 reports
- Python® Embolectomy Catheter A4E08Catheter, Embolectomy12 reports
- Python® Embolectomy Catheter A4E05Catheter, Embolectomy7 reports
- Python® Embolectomy Catheter A4E01Catheter, Embolectomy2 reports
- Python® Embolectomy Catheter A4E02Catheter, Embolectomy2 reports
- Python® Embolectomy Catheter A4E06Catheter, Embolectomy1 report
Recent Python Embolectomy Catheter adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionJun 22, 2018Burst Container or Vessel; Burst Container or Vessel
PROCEDURE PERFORMED: "THROMBECTOMY" EVENT DESCRIPTION: ON (B)(6) 2018: DURING A PREPARATION FOR PROCEDURE [PROCEDURE: THROMBECTOMY]. THE PYTHON CATHETER A4E03 WAS OPENED. DURING PRE-USE CHECK: WHEN A MEDICAL STAFF TRIED TO INFLATE THE BALLOON IN THE PATIENT'S VESSEL, THE STAFF FOUND LEAK AROUND INFLATION TUBE. THE MEDICAL STAFF REALIZED THAT THE INFLATION TUBE WAS BROKEN. THE MEDICAL STAFF ELECTED TO USE ANOTHER PYTHON CATHETER A4E06 FOR THE SURGERY. DURING PRE-USE CHECK: WHEN THE MEDICAL STAFF TRIED TO INFLATE THE BALLOON, THE BALLOON WAS RUPTURED. THE MEDICAL STAFF ELECTED TO USE ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. THIS EVENT DIDN'T AFFECT THE PATIENT." COMMENTS FROM (B)(6): COMPLAINT SAMPLE WAS RETURNED FROM THE HOSPITAL. THE SAMPLE WILL BE RETURNED TO APPLIED MEDICAL. INVESTIGATION REPORT FOR THIS CASE IS REQUIRED. TYPE OF INTERVENTION: "THE MEDICAL STAFF ELECTED TO USE ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED WITH NO PROBLEM." PATIENT STATUS: "THIS EVENT DIDN'T AFFECT THE PATIENT."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7631626 ↗MalfunctionJun 7, 2018Burst Container or Vessel; Burst Container or Vessel
PROCEDURE PERFORMED: THROMBECTOMY. THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR INVESTIGATION, HOWEVER, WE WOULD LIKE YOU TO ISSUE CREDIT FOR THIS CASE. EVENT DESCRIPTION: "ON (B)(6) 2018: DURING A PROCEDURE [PROCEDURE: THROMBECTOMY], THE PYTHON CATHETER A4E01 WAS USED FOR THE SURGERY. THE PYTHON CATHETER WAS RUPTURED WHEN A MEDICAL STAFF TRIED TO REMOVE A THROMBUS FROM A BLOOD VESSEL. ANOTHER PACKAGE OF PYTHON CATHETER WAS OPENED AND USED FOR THE SURGERY. THE PROCEDURE WAS COMPLETED WITH NO PROBLEM. NO HEALTH DAMAGE WAS REPORTED FOR THE PATIENT. COMMENTS FROM (B)(4): COMPLAINT SAMPLE WAS NOT RETURNED FROM THE HOSPITAL BECAUSE THE SAMPLE WAS DISCARDED AT HOSPITAL. THE BALLOON WAS INSPECTED PRIOR TO USE FOR THE SURGERY. ACCORDING TO THE USER, THEY DIDN'T APPLY EXCESSIVE PRESSURE TO THE BALLOON. INVESTIGATION REPORT FOR THIS CASE IS REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON 15.MAY.2018 FROM (B)(4), DISTRIBUTOR. THE BALLOON DID NOT OCCLUDE THE VESSEL. "THE SURGEON REMOVED THE RUPTURED CATHETER, THEN THE SURGEON ELECTED TO USE ANOTHER PYTHON CATHETER TO CONTINUE THE SURGERY. THE PROCEDURE COMPLETED WITHOUT ANY PROBLEM." THERE WAS NO DAMAGE TO THE VESSEL. "ACCORDING TO THE
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7580925 ↗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 ↗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 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 ↗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 ↗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 ↗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 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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