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

Catalog Number	ADM06025013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used the impact admiral with a 6f cook sheath, spider fx and cook inflation device with 50/50 contrast to treat a calcified plaque soft tissue cto, with little calcification and no vessel tortuosity, in the mid superficial femoral artery.The device was prepped as per ifu with no issues identified.No resistance was encountered advancing the device, no excessive force was used, the device did not pass through a previously deployed stent.It was reported the balloon was inflated to 6atm when a perforation in the superficial femoral artery occurred, the perforation was treated with a poba tamponade and covered with bare metal stenting.No further patient injury reported.
Additional Manufacturer Narrative
Additional information reported that the perforation of the vessel occurred during initial inflation to 5 atm post da.The current status of the patient is reported to be good 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: 8310033
• Report Number: 9612164-2019-00436
• Device Sequence Number: 2203463
• Product Code: ONU
• UDI-Device Identifier: 00643169975088
• UDI-Public: 00643169975088
• 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): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2021
• Device Catalogue Number: ADM06025013P
• Device Lot Number: 0009276235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 02/11/2019; 04/25/2019
• Initial Report FDA Received Date: 02/06/2019
• Supplement Report FDA Received Date: 03/04/2019; 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention