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

Catalog Number	PTA5-35-80-5-2.0
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is related to manufacturer report number 1820334-2017-01886.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
The device was used for endovascular therapy.The target lesion was the right superficial femoral artery (sfa); the approach was antegrade through the right common femoral artery.The lesion was described as a chronic total occlusion.The right sfa lesion was pre-dilated with a 0.014 inch balloon to place ptx stent(s).The pta5-35-80-5-2.0 balloon ruptured at 18 atm (atmospheres) after replacing a ruptured pta5-35-80-5-4.0 balloon.This balloon was replaced with another pta5-35-80-5-2.0 balloon that also ruptured.However, the procedure was successfully completed with the pta5-35-80-5-2.0 since the stent was sufficiently post-dilated.There were no reported adverse effects to the patient.

• 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: 6745254
• Report Number: 1820334-2017-02153
• Device Sequence Number: 1371626
• Product Code: DQY
• UDI-Device Identifier: 10827002523378
• UDI-Public: (01)10827002523378(17)170730(10)5175313
• Combination Product (Y/N): N
• PMA/510(K) Number: K091527
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/26/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PTA5-35-80-5-2.0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 07/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1