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

Catalog Number	ADM06004013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
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
The physician intended to use the inpact admiral.It was reported the first inpact used could not be inflated due to a leak on the catheter.The physician attempted to use a second inpact, but encountered the same issue.A third inpact was used to complete the procedure with no issues noted.No patient injury was reported.
Additional Manufacturer Narrative
The ifu was followed and the device was prepped without issue.A non-medtronic 6fr sheath and 0.035 guidewire were used.Neg prep was also performed.A leak where the catheter and hub meet was observed.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The device was returned for evaluation.A visual and tactile inspection was performed on the device.The balloon was unfolded.Guidewire was easily inserted.The purging procedure was performed, but revealed a leak, since the bubble flow under negative pressure did not stop.The rubber was removed from its original position.In order to verify the point of leak, an attempt was done to inflate the balloon and the leak was found on the distal part of the hub.The leak was found in the distal hub bonding, between the shaft and the glue collar.It was possible to inflate the balloon, but the device did not hold the pressure.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: 8114919
• Report Number: 9612164-2018-03415
• Device Sequence Number: 19220637
• Product Code: ONU
• UDI-Device Identifier: 00643169383258
• UDI-Public: 00643169383258
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2021
• Device Catalogue Number: ADM06004013P
• Device Lot Number: 0009280222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 12/13/2018; 01/24/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 01/07/2019; 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1