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

Catalog Number	PTA5-35-80-10-4.0
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/30/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 low profile balloon catheter was used for ppi (percutaneous peripheral intervention) on a patient with stenosis in the left cia (common iliac artery).The stenosis was for 5cm in length from the cia bifurcation.Another manufacturer's 6 fr sheath was used together with the device.The device was inserted over a 0.018inch wire guide into the sheath by ipsilateral approach.During advancement, the device got stuck inside the sheath and could not reach to the lesion.Then, the wire guide was changed with 0.035inch wire guide to aid the device advancement to the lesion.However, the devices were removed because the low profile balloon catheter was still stuck.Since a kink in the shaft was visually observed, the physician stopped using the device.It was further noted that the catheter had a "damaged/twisted motion near the balloon" with a tear in the catheter of the pta balloon.Another low profile balloon catheter was used to complete the procedure without any problems.There have been no adverse effects to the patient reported.

• 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: 6719691
• Report Number: 1820334-2017-01952
• Device Sequence Number: 19141551
• Product Code: DQY
• UDI-Device Identifier: 10827002523736
• UDI-Public: (01)10827002523736(17)170731(10)5178619
• Combination Product (Y/N): N
• 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): 07/17/2017

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: PTA5-35-80-10-4.0
• 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: 07/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1