MAUDE Adverse Event Report: COOK INC ADVANCE 18 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G34339

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problems Thrombus (2101); Foreign Body In Patient (2687); No Code Available (3191)

Event Date 02/26/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation = office manager.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during a revascularization procedure of the superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured circumferentially at 22 atmospheres.A cook sphere inflation device was used to inflate the balloon one time with a 50/50 ratio of omnipaque contrast.The 70% stenosed lesion was at the origin of a previous superficial femoral-popliteal bypass anastomosis.No calcification or tortuosity was reported.The balloon was unable to be removed by itself; therefore, the balloon was removed together with a 5 french 45 centimeter ansel sheath and unknown wire guide.After removal, the user realized that the distal one-third of the balloon had separated, and part of the balloon was left in the patient.Blood was noted in the inflation device as the device was withdrawn.The balloon was not inflated within a stent prior to rupture.The patient reportedly presented to the emergency room the following day with a thrombus "cold leg".Emergency surgery was performed.Additional information has been requested, but is unavailable at this time.

Event Description

Additional information was received.The physician attempted removal of the separated portion of the balloon at the time of the event.The reporter confirmed that the patient had a blood clot.The patient is reportedly doing well.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during a revascularization procedure of the superficial femoral artery, an advance 18 lp low profile balloon catheter ruptured circumferentially at 22 atmospheres.A cook sphere inflation device was used to inflate the balloon one time with a 50/50 ratio of omnipaque contrast.The 70% stenosed lesion was at the origin of a previous superficial femoral-popliteal bypass anastomosis.No calcification or tortuosity was reported.The balloon was unable to be removed by itself; therefore, the balloon was removed together with a 5 french 45-centimeter ansel sheath and unknown wire guide.After removal, the user realized that the distal one-third of the balloon had separated, and part of the balloon was left in the patient.Blood was noted in the inflation device as the device was withdrawn.The balloon was not inflated within a stent prior to rupture.The patient reportedly presented to the emergency room the following day with a thrombus "cold leg".Emergency surgery was performed.The physician attempted removal of the separated portion of the balloon at the time of the event.The reporter confirmed that the patient had a blood clot.The patient is reportedly doing well.Investigation evaluation: a review of the complaint history, device history record, drawing, documentation, instructions for use (ifu), manufacturing instructions, quality control, specifications, and a visual inspection of the complaint device was conducted during the investigation.The complainant returned one used pta4-18-150-7-4 to cook for investigation.Physical examination of the returned device confirmed that the balloon had ruptured circumferentially.There was biomatter present on the returned device.Only 1.8cm of the balloon remained on the catheter shaft and there was only one marker band present.A document review was completed as a response to this event.A device master record review was performed, including device specifications, drawings, manufacturing instructions, and quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.No related non-conformances were found, and there have been no other reported complaints for this lot number.The information provided upon review of complaint file, device history record, complaint history, device master record, and design validation testing provide objective evidence to support that the device was manufactured to specification.The product ifu warns: ¿do not exceed rated burst pressure.Rupture of balloon may occur.Adhere to balloon inflation pressure parameters in the compliance card insert.¿ based on the information provided and the results of the investigation, cook has concluded that use error most likely contributed to this incident.The rated burst pressure for the device is 14 atmospheres; however, the user inflated the balloon to 22 (8 atm over the rated burst pressure).The ifu warnings state ¿do not exceed rated burst pressure.Rupture of balloon may occur.¿ the risk analysis for this failure mode was reviewed and no additional escalation was required.The appropriate personnel have been notified and cook will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ADVANCE 18 LP LOW PROFILE BALLOON CATHETER
• Type of Device: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9834960
• MDR Text Key: 196399282
• Report Number: 1820334-2020-00614
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002343396
• UDI-Public: (01)10827002343396(17)211107(10)9294400
• Combination Product (y/n): N
• PMA/PMN Number: K130293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/07/2021
• Device Model Number: G34339
• Device Catalogue Number: PTA4-18-150-7-4
• Device Lot Number: 9294400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Date Manufacturer Received: 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 63 YR