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

Model Number	ADM06012013P
Medical Device Problem Codes	Deflation Problem (1149); Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the device was decontaminated with cidex opa solution soak and tergazyme soak pending further device testing to support the final product analysis findings.The device returned entrapped in a non-medtronic sheath with bunching of balloon material against the distal tip of the sheath.Clear liquid was present in the balloon.Deformation was evident to the distal tip of the complaint device.A tactile test detected a crush to the shaft.A 0.035inch guidewire was loaded via the distal tip but could not be advanced through the lumen due to the present of hardened blood.The device was unable to be removed from the sheath due to the bunching present in the balloon material.Deflation was attempted but was not successful as liquid was still present in the distal end of the balloon.The device was dissected proximal to the sheath and the balloon and portion of the shaft were removed distally from the sheath.Liquid was present inside the balloon with the balloon material bunched.The balloon folds were open.No other damage was found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician attempted to use an inpact admiral drug coated balloon with a non-medtronic 6fr sheath during a procedure to treat a lesion in the patient¿s mid superficial femoral artery (sfa).An inflation device was used for balloon inflation.There was no damage noted to packaging, i.E.Shelf carton, hoop/tray.There were no issues noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped without issue.The device was not passed through a previously deployed stent.No resistance was encountered during advancement.It is reported the inapct admiral was incompatible with the 6fr sheath.The physical had to pull the entire sheath with the balloon inside out.A second sheath was then placed, and the procedure completed.No patient injury reported.

• 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: 12092434
• Report Number: 9612164-2021-02546
• Device Sequence Number: 17144983
• Product Code: ONU
• UDI-Device Identifier: 00643169859975
• UDI-Public: 00643169859975
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/30/2021

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: 05/22/2023
• Device Model Number: ADM06012013P
• Device Catalogue Number: ADM06012013P
• Device Lot Number: 0010255210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1