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

Catalog Number ADM04015008P

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician intended to use an inpact admiral to treat an 150mm moderately calcified lesion with 90% stenosis in the superficial femoral artery (sfa).The lesion was accessed through the femoral artery.A non-medtronic introducer and non-medtronic 5fr 11 sheath and a non-medtronic 0.014 235cm guidewire were also used.The inpact admiral device was inspected and prepped before use and negative prep was completed with no issues.Pre-dilation was completed with a non-medtronic 4mm-100mm device (2 times).Post dilation was not completed.It was reported that after inflation of the device, the physician attempted to remove the device from the patient but encountered strong resistance.The balloon fractured and the shaft broke and it was difficult to remove from the patient.The fractured inpact, guidewire and sheath were removed together.A puncture was performed separately with an 18g needle.The physician believes that the issue was caused by the tip of the inpact getting trapped in the blood vessel or the 14 wire which was used.It was confirmed under angiography that no parts of the device remained in the patient.The procedure was extended for 30mins or longer.

Manufacturer Narrative

Product analysis: the device was returned with the non-mdt 0.014-inch guidewire loaded.The device was badly damaged upon visual inspection.Kinks/damage were evident along the catheter and balloon segments.The balloon was returned in segments.Congealed blood was clearly visible on the 0.014-inch guidewire and within the guidewire lumen of the device.The catheter was stretched and flattened 50.4 cm distal from strain relief extending to 61.3 cm.The catheter was torn at the proximal balloon marker.The distal tip was not returned with the device and the guidewire protruded through the damaged distal portion of the device.Damage was observed on the guidewire which seems consistent with the reported intervention attempt.If information is provided in the future, a supplemental report will be issued.

• 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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8365797
• MDR Text Key: 137042092
• Report Number: 9612164-2019-00622
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Catalogue Number: ADM04015008P
• Device Lot Number: 0009316409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 02/25/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1