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

Catalog Number PTA4-18-150-5-20

Device Problems Material Rupture (1546); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

(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 percutaneous transluminal angioplasty of the superficial femoral artery with stent placement, an advance 18 lp low profile balloon catheter ruptured and separated.Access was obtained in the radial artery.The balloon material was snared from the patient.Additional information has been requested, but is unavailable at this time.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.

Event Description

Additional information was received 05jan2021.An unknown sheath was used during the procedure.An unknown inflation device was used to inflate the balloon after a stent was placed in the superficial femoral artery, using two milliliters of contrast and eight milliliters of saline.The inflation pressure is unknown.It is possible that the balloon was inflated in or near the stent.It is unknown how many times the balloon was inflated prior to rupturing circumferentially.It is unknown if the balloon was removed from the body and reinserted between inflations.The vessels were calcified but were not angulated or tortuous.Blood was not noted in the inflation device.The procedure was completed successfully.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Summary of event: as reported, during percutaneous transluminal angioplasty of the superficial femoral artery with stent placement, an advance 18 lp low profile balloon catheter ruptured and separated.Access was obtained in the radial artery.The balloon material was snared from the patient.Additional information was received 05jan2021.An unknown sheath was used during the procedure.An unknown inflation device was used to inflate the balloon after a stent was placed in the superficial femoral artery, using two milliliters of contrast and eight milliliters of saline.The inflation pressure is unknown.It is possible that the balloon was inflated in or near the stent.It is unknown how many times the balloon was inflated prior to rupturing circumferentially.It is unknown if the balloon was removed from the body and reinserted between inflations.The vessels were calcified but were not angulated or tortuous.Blood was not noted in the inflation device.The procedure was completed successfully.Upon return and initial evaluation of the device on 12jan2021, the proximal fitting was not attached to the balloon catheter.Investigation evaluation: reviews of the drawing, documentation, instructions for use (ifu), manufacturing instructions, quality control, personnel interview, and specifications were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complainant returned one used balloon catheter to cook for investigation.Physical examination of the returned device confirmed that the balloon was ruptured circumferentially in two places.The proximal fitting including the strain relief and hub were separated from the catheter shaft and not returned with the device.Biomatter was present on the returned device.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.Cook could not complete a review of the device history record (dhr) due to lack of lot information from the user facility.The information provided upon review of complaint file, device master record, and design verification testing provides objective evidence to support that the device was manufactured to specification.There is no evidence that there is non-conforming product in-house or in the field.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.Over-inflation may cause rupture of the balloon, which resultant damage to the vessel wall.Use of a pressure gauge is recommended to monitor inflation pressures.¿ the ifu instructs: ¿if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.¿ based on the information provided and the results of the investigation, cook has concluded that the patient¿s anatomy and the procedure contributed to this incident.Reportedly, the patient¿s vessels were calcified, and it is possible that the balloon was inflated within or near an unknown stent.The proximal fitting detaching from the device is believed to be contributed to the force applied when trying to remove the ruptured balloon.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.

Event Description

Upon return and initial evaluation of the device, the proximal fitting was not attached to the balloon catheter.

• 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: 11089224
• MDR Text Key: 224173728
• Report Number: 1820334-2020-02373
• Device Sequence Number: 1
• Product Code: LIT
• 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,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTA4-18-150-5-20
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention