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

Catalog Number	PTA5-35-80-7-4.0
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/19/2015
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
A patient with pad (peripheral artery disease) underwent pta (percutaneous transluminal angioplasty) against the isr (in-stent restenosis) with another manufacturer's device; it was placed in the right popliteal artery and was performed by ipsilateral antegrade approach from the right femoral artery.After the target isr was dilated twice with the complaint balloon by applying 8 atm pressure, the physician attempted to dilate the isr further by applying 12 atm pressure to the balloon.However, although 12 atm was the rbp (rated burst pressure) of this product, the balloon ruptured once it reached 12 atm.The device was replaced with another 35lp balloon of a different length which was inflated to 12 atm pressure without problems.The physician noted that this event was possibly affected by severe calcification of the lesion and the fact that the device was used to isr.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: 6717806
• Report Number: 1820334-2017-01955
• Device Sequence Number: 1601961
• Product Code: DQY
• UDI-Device Identifier: 10827002523521
• UDI-Public: (01)10827002523521(17)180115(10)5580508
• 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: PTA5-35-80-7-4.0
• 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