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

Model Number ADM05020013P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Intimal Dissection (1333)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event 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
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10161559
• MDR Text Key: 195388144
• Report Number: 9612164-2020-02220
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 00643169975019
• UDI-Public: 00643169975019
• 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
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/17/2020
• Date Device Manufactured: 09/07/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 79