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

Catalog Number ADM06004013P

Device Problems Leak/Splash (1354); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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.

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
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7714681
• MDR Text Key: 115190663
• Report Number: 9612164-2018-01843
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169383258
• UDI-Public: 00643169383258
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 08/03/2018; 08/08/2018
• Supplement Dates FDA Received: 08/29/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1