MAUDE Adverse Event Report: COOK INC ADVANCE 35 LP LOW PROFILE BALLOON CATHETER; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Codes	Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Date of Event	10/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.
Event or Problem Description
An advance 35 lp low profile balloon catheter was used in an angioplasty procedure.It was reported that the balloon broke/ruptured at 8atm, at the tip, while in the patient and a piece of the tip separated from the device.They tried to retrieve the piece with a snare, but were unsuccessful.A small stent was placed over the fragment so that it would not migrate into the lung.According to the initial reporter, the patient did not experience any other adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and inspection of the returned unused device was conducted during the investigation.The complaint device was unable to be returned; however an unused advance 18 lp low profile balloon catheter of the same lot was returned for evaluation.No surface defects or damage was noted to the catheter shaft or balloon.Crow's feet were present.The balloon was able to be inflated to 12atm without rupture.The device met dimensional requirements.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other related complaints for this lot number.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue.Therefore, based upon the information provided, no product returned; a definitive root cause could not be determined.

• Brand Name: ADVANCE 35 LP LOW PROFILE BALLOON CATHETER
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6956715
• Report Number: 1820334-2017-03629
• Device Sequence Number: 11040665
• Product Code: DQY
• UDI-Device Identifier: 10827002523743
• UDI-Public: (01)10827002523743(17)200125(10)7621940
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTA5-35-80-10-6.0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR