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

Model Number	ADM05020013P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	05/27/2020
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
Physician used a hawkone and a 5 x 100 in.Pact admiral during treatment of a moderately calcified plaque lesion in the right proximal sfa with 80% stenosis.The vessel diameter and lesion length are 5.5mm and 80mm respectively.The vessel is little tortuous a non medtronic 6fr sheath, medtronic 0.014 guide wire and 5mm spider fx were used.A small dissection was noticed at the target lesion post hawk usage.The physician decided to go in with the drug coated balloon and the dissection extended from the original.A stent was then placed across the dissection.An evercross pta balloon was attempted to cross the newly deployed stent but it failed.There was not damage to device packaging.There was no issues noted when removing device from hoop/tray.The device was prepped per ifu with no issued identified.There was severe resistance encountered when advancing the device.The device was safely removed from the patient.A nanocross pta balloon was used to cross the lesion and complete the procedure.There was no further patient injury reported.

• 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 ; IE
• MDR Report Key: 10161559
• Report Number: 9612164-2020-02220
• Device Sequence Number: 3573245
• Product Code: ONU
• UDI-Device Identifier: 00643169975019
• UDI-Public: 00643169975019
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/17/2020

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: 09/06/2021
• Device Model Number: ADM05020013P
• Device Catalogue Number: ADM05020013P
• Device Lot Number: 0009316080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/17/2020
• 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
• Patient Age: 82 YR
• Patient Weight: 79