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

Catalog Number	ADM05015013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used a balloon on 100% stenosis within a stent in the distal superficial femoral artery(sfa).The lesion was described as a chronic total occlusion(cto) of 150mm in length of soft tissue, plaque with slight calcification and slight tortuousity in an artery of diameter of 5mm.This was then followed by atherectomy.The physician then wanted to use an inpact admiral dcb balloon.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.The device was prepped without issue.A 6fr non-medtronic sheath and a 0.014 nitrex guidewire were used with no embolic protection.The device did pass through a previously deployed stent, no resistance was encountered nor excessive force used on advancing the device to the target lesion.The device was inflated with a non-medtronic inflation device to 8atm.It was reported that the inpact admiral was leaking pressure.The balloon and all fragments were reported to have been retrieved.No patient injury was reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: it was reported the distal of the balloon was leaking.A nanocross was used for post dilation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8594583
• Report Number: 9612164-2019-01634
• Device Sequence Number: 2180629
• Product Code: ONU
• UDI-Device Identifier: 00643169576339
• UDI-Public: 00643169576339
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2019

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: 08/18/2019
• Device Catalogue Number: ADM05015013P
• Device Lot Number: 0009474041
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/16/2019; 06/14/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 05/27/2019; 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 90