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

Catalog Number	ADM05012013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2018
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
It was reported that the physician was attempting to use an inpact admiral balloon catheter however the balloon burst or leaked.No patient injury was reported.
Additional Manufacturer Narrative
Evaluation summary: the device was returned with the tray.The red protection was still loaded on the balloon.No issue was noted.During the technical analysis a 0.035¿ guidewire was successfully advanced through the device.The red protection was removed and blood was found on the balloon which was still folded.Purging was performed which revealed a leak.An inflation attempt was made showing leaks in three points of the balloon.The balloon was observed under the microscope and three cuts on the balloon surface were detected.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Event occurred during device preparation, prior to insertion into the introducer sheath.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: 8063481
• Report Number: 9612164-2018-03158
• Device Sequence Number: 2575447
• Product Code: ONU
• UDI-Device Identifier: 00643169383630
• UDI-Public: 00643169383630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/22/2019

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: 03/29/2019
• Device Catalogue Number: ADM05012013P
• Device Lot Number: 0008557371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2018
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 12/07/2018; 01/17/2019
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/13/2018; 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1