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

Catalog Number ADM05008008P

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the device returned with no damage visible to the catheter.A 0.035inch guidewire was loaded via the distal tip with no resistance noted.The device failed negative prep.Upon pressurisation of the device, multiple pin hole leaks were observed in a linear pattern along the entire length of the balloon material.The balloon material at the pin-hole tear sites was jagged, uneven and protruding outwards in a distal direction.Damage was evident to the balloon material along the length of the balloon, with scratch/indentation marks visible.Damage was evident to the distal tip.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: there were no difficulties removing the balloons from the patient.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Physician intended to use an impact admiral drug coated balloon during treatment of a calcified lesion in the patient¿s proximal right superficial femoral artery (sfa).Moderate vessel calcification and slight tortuosity are reported.Lesion exhibited 95% stenosis.Ifu was followed and the device was prepped without issue.The balloon was passed through a previously deployed stent without resistance encountered.An inflation device was used for balloon inflation.It is reported a balloon rupture occurred on second inflation at a pressure of 8atm.The balloon was removed from the patient without leaving fragments behind.A second impact admiral device was prepped as per ifu and advanced through the previously deployed stent without encountering resistance.It is reported the balloon could not be inflated past 2 atm and lost pressure continuously.Contrast was observed to be leaking from the balloon.When the balloon was removed from the patient, 2 holes were observed on the balloon.The procedure was then completed via plain old balloon angioplasty.No 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
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9652419
• MDR Text Key: 188583189
• Report Number: 9612164-2020-00502
• Device Sequence Number: 1
• Product Code: ONU
• 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,Followup,Followup
• Report Date: 02/25/2020

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: 03/12/2021
• Device Catalogue Number: ADM05008008P
• Device Lot Number: 0009031840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 01/31/2020; 02/24/2020
• Supplement Dates FDA Received: 02/03/2020; 02/25/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• 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