MAUDE Adverse Event Report: MEDTRONIC IRELAND IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Catalog Number	ADM06004013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use an in.Pact admrial during treatment of an 85% stenosed lesion in the patient¿s right proximal tibial/popliteal trunk.Slight calcification was reported.Ifu was followed and the device was prepped without issue.During inflation of the device at a pressure of 2 atms a small hole at the proximal end of the catheter shaft about an inch from the hub.This resulted in the balloon pressure continuing to drop during inflation.No hole in balloon or leak at the hub reported.The procedure was completed with this balloon.No patient injury reported.
Additional Manufacturer Narrative
Product analysis: the device was returned for evaluation.A visual and tactile inspection was performed on the device.The balloon was unfolded.During the purging procedure, the bubble flow under negative pressure did not stop and a leak was discovered.The rubber was removed from its original position.In order to verify the point of leak, an attempt was made to inflate the balloon and the leak was found on the distal part of the hub.The leak was found in the distal bonding, between the shaft and the glue collar.It was possible to inflate the balloon but the device did not hold the pressure.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7714681
• Report Number: 9612164-2018-01843
• Device Sequence Number: 16472799
• Product Code: ONU
• UDI-Device Identifier: 00643169383258
• UDI-Public: 00643169383258
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/13/2019
• Device Catalogue Number: ADM06004013P
• Device Lot Number: 0008491930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 08/03/2018; 08/08/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/29/2018; 10/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1