MAUDE Adverse Event Report: COOK INC ADVANCE 14 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number G50339

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation = unknown.Pma/510(k) number= k170193.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, prior to patient contact during an angiogram of the lower leg, "plastic strands" came off of an advance 14 lp low profile balloon catheter balloon as it was wiped down.The strands were approximately one inch in length.The device did not make patient contact.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Event summary: as reported, prior to patient contact during an angiogram of the lower leg, "plastic strands" came off of an advance 14 lp low profile balloon catheter balloon as it was wiped down.The strands were approximately one inch in length.The device did not make patient contact.Investigation - evaluation: reviews of the complaint history, device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, specifications and quality control procedures and a visual inspection of the device were conducted during the investigation.The user returned one prior to use ptax4-14-170-4-16 for investigation.The balloon was inflated.Strands of hydrophilic coating were visible coming off the balloon surface.A document-based investigation evaluation was also performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.No gaps were discovered in the manufacturing instructions, specifications, drawing, or quality control procedures for this device.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The product is packaged with instructions for use, which state, ¿upon removal from package, inspect catheter to ensure no damage has occurred during shipping,¿ and, ¿activate the hydrophilic coating by wiping the balloon with heparinized saline solution.¿ based on the information available, investigation has concluded that a cause could not be established for this event.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.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 14 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: 9539150
• MDR Text Key: 178146013
• Report Number: 1820334-2020-00032
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 10827002503394
• UDI-Public: (01)10827002503394(17)220724(10)9903180
• Combination Product (y/n): N
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/24/2022
• Device Model Number: G50339
• Device Catalogue Number: PTAX4-14-170-4-16
• Device Lot Number: 9903180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 06/17/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1