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

Catalog Number	PTA5-35-135-3-12.0
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation- a review of the device history record, documentation, specifications, instructions for use (ifu), quality control (qc) and a visual inspection of the complaint device was conducted for the purpose of this investigation.One used device returned for investigation.There is discoloration and a jagged separation and the proximal end of the shaft indicative of excessive force contributing to separation.The balloon shows signs of a circumferential burst.There are longitudinal striations present on this portion of balloon perhaps from pulling the balloon through an area of resistance or into the sheath after rupture.Both marker bands are intact.A review of device history records found the balloon from the complaint lot to be the only device manufactured in this lot.No non conformances or re-works were logged by quality control against this lot.Per qc, instructions are in place to verify the device is manufactured to specifications.Each device is shipped with ifu, which states the appropriate uses, contraindications, warnings and precautions, and proper usage procedures including proper inflation and deflation procedures.The ifu states: do not exceed rated burst pressure and do not use a power injector for balloon inflation or injection of contrast medium as rupture may occur.The ifu also states, if balloon pressure is lost and/or balloon rupture occurs, deflate balloon and remove balloon and sheath as a unit.The nominal inflation for this device is 10 atm and the rated burst pressure is 15 atm.The balloon was ruptured below this range, therefore over-inflation is not suspected to have caused the balloon to burst.It is unknown how the device was withdrawn from the patient.The device is designed to burst linearly.However, a balloon may burst or tear circumferentially due to angulation or calcification.Calcifications can have unexpected sharp protrusions which can damage the balloon and contribute to burst or tear.At this time, the patient anatomy is unknown.There is no evidence to suggest the product was not manufactured to specification.Based on this evaluation we are unable to determine a root cause.The appropriate personnel will be notified and will continue to monitor for similar complaints.
Event or Problem Description
Initial information provided on 20apr2016 stated: during the lower limb surgery, the balloon ruptured when inflating it to 8 atm.Upon inspection of the return device on 26may2016, it was determined that the balloon had ruptured circumferentially making it a reportable event.Additional information was requested, however it was not provided at the time of this report.

• 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: 5741185
• Report Number: 1820334-2016-00431
• Device Sequence Number: 946612
• Product Code: DQY
• UDI-Device Identifier: 10827002522494
• UDI-Public: (01)10827002522494(17)190105(10)NS6496501
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: PTA5-35-135-3-12.0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2016
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2016
• Initial Report FDA Received Date: 06/22/2016
• 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: Other