MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number PTA5-35-135-6-20.0

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 01/05/2018

Event Type  Injury  

Manufacturer Narrative

Common name & product code = unavailable as the device lot number, rpn, and gpn are unknown.Pma/510(k) number = unavailable as the device lot number, rpn, and gpn are unknown.(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

It was reported that during an unspecified procedure, a cook medical balloon catheter ruptured.The patient's tissue was cut down in order to retrieve the ruptured balloon.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional information regarding event details and patient anatomy has been requested, but is not available at this time.

Manufacturer Narrative

Additional information received on 27feb2018: the ruptured balloon catheter was an advance 35 lp low profile balloon catheter (lot 8017024).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the balloon ruptured circumferentially 30 mm from the distal tip.There were three kinks in the catheter, which were 80 mm, 84 mm, and 95 mm from the distal tip of the device.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this failure mode.We will continue to monitor for similar complaints.Per the risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: ADVANCE 35 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: 7213753
• MDR Text Key: 98043559
• Report Number: 1820334-2018-00125
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K132020
• 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: 03/28/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: PTA5-35-135-6-20.0
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/05/2018
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 02/27/2018; 03/27/2018
• Supplement Dates FDA Received: 02/27/2018; 03/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention