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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during an attempt to treat a lesion using in.Pact admiral paclitaxel eluting balloon catheter, the balloon burst below nominal pressure during inflation.No patient injury reported for this event.
Additional Manufacturer Narrative
Evaluation codes: results: 23 manufacturing deficiency ¿ weld issue device evaluation: a visual inspection was performed on the catheter.It was found blood-stained both inside and outside of the balloon.The inflation lumen presented also clots of blood inside.The balloon does not show damage.It was possible to insert a 0,035¿¿ guide wire despite the blood clots obstructing the guidewire channel.Negative pressure was applied and a leak appeared evident.Once positive pressure was applied, the balloon was found leaky from the proximal balloon welding.The welding was analyzed under a microscope and the hole was measured.It looks like a little burst, directed from inside towards outside.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: 6618526
• Report Number: 9612164-2017-00673
• Device Sequence Number: 16166915
• 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): 06/22/2017

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 Expiration Date: 03/02/2018
• Device Catalogue Number: ADM06004013P
• Device Lot Number: 0007960508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 06/22/2017; 06/22/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 07/14/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1