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

Model Number	ADM05020013P
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the inpact admiral device was returned to medtronic investigation lab for evaluation.The device was returned with a guidewire entrapped in the device and a detachment at the shaft of the complaint device with the detached portion of the shaft and balloon entrapped in a non-medtronic sheath.Multiple sites of deformation were evident to the shaft of the device.Balloon bunching was evident immediately distal to the distal tip of the sheath with some fluid evident in the balloon.Slight deformation was present to the distal tip consistent with use of the device.The sheath was cut, and the entrapped section of the device was removed.The balloon folds were open.Multiple dents were evident to the shaft.A 0.035inch guidewire was loaded via the distal tip but was not possible to advance through the device due to the detachment and damage.Device removal recreation was not possible due to entrapment of the device in the sheath.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was attempting to use inpact admiral paclitaxel eluting balloon catheter during procedure to treat the superficial femoral artery (sfa).The balloon was inflated using an inflation device.There was no damaged noted to packaging.There was no issue noted when removing the device from hoop/tray.The device was prepped per ifu with no issues identified.Removal difficulties occurred.It was reported that there was difficulty removing balloon following inflation.There was no resistance encountered when advancing the device.There were no difficulties noted during balloon deflation.The balloon was fully deflated when removal attempt made.The sheath and inpact admiral were removed in tandem.No intervention required for removal.Device was safely removed from patient.There was no patient injury.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12340783
• Report Number: 9612164-2021-03192
• Device Sequence Number: 3938774
• Product Code: ONU
• UDI-Device Identifier: 00643169975019
• UDI-Public: 00643169975019
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: ADM05020013P
• Device Catalogue Number: ADM05020013P
• Device Lot Number: 0010237462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1