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

Catalog Number ADM04008008P

Device Problem Burst Container or Vessel (1074)

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

Event Date 01/28/2020

Event Type  malfunction  

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

Product analysis: device was received into medtronic investigation lab for evaluation.Deformation was evident to the catheter 55.4cm, 59.9cm and 69.7cm distal to the strain relief.Deformation was evident to the distal tip.A 0.035 inch guide wire was loaded through the device with no issues noted.Negative prep detected the presence of a leak on the device.Upon pressurisation, a longitudinal tear was visible on the distal balloon cone.The balloon material was jagged and uneven at the tear site.The balloon material was bunched and deformed both proximal and distal to the tear site.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 inpact 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 inpact 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: 9652415
• MDR Text Key: 188583056
• Report Number: 9612164-2020-00501
• 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: 02/21/2020

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: 12/04/2020
• Device Catalogue Number: ADM04008008P
• Device Lot Number: 0008906068
• 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; 02/19/2020
• Supplement Dates FDA Received: 02/03/2020; 02/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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