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

Catalog Number ADM07004008P

Device Problem Burst Container or Vessel (1074)

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

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used an inpact admiral during patient treatment.An inflation device was used with saline and contrast for balloon inflation.No damage noted to packaging prior to use nor issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.No resistance was noted during advancement of the device.It is reported a balloon burst occurred during last balloon inflation at 14atm.2 prior inflations had been applied to the device.No balloon fragments were left in the patient.No injury reported.

Manufacturer Narrative

Product analysis: the inpact admiral device was returned to medtronic investigation lab for evaluation.The device was returned with blood and residue visible within the balloon and catheter.A 0.035 inch guide wire was loaded through the inner lumen with no resistance noted.Negative prep did not detect the evidence of a leak on the device.Upon pressurization of the device a pin-hole leak was observed on the mid balloon material.There were multiple scratches and damage evident to the balloon material surrounding the site of the pin-hole tear.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the in.Pact admiral was using during the treatment of a calcified lesion in the patient's superficial femoral artery (sfa).The type of balloon burst is unknown.The balloon did not fragment.There were no difficulties experienced when removing the device from the patient.No extra steps were required to complete the procedure.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.

• 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: 9785649
• MDR Text Key: 190331508
• Report Number: 9612164-2020-01005
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup,Followup
• Report Date: 05/20/2020

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: 07/05/2020
• Device Catalogue Number: ADM07004008P
• Device Lot Number: 0009529438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/04/2020
• Supplement Dates Manufacturer Received: 03/05/2020; 03/09/2020; 05/18/2020
• Supplement Dates FDA Received: 03/09/2020; 03/12/2020; 05/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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