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

Catalog Number	ADM05012013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2018
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
It was reported that the physician intended to use an in.Pact admiral with a non-mdt 6f sheath for the treatment of a lesion type in the patients mid superficial femoral artery(sfa).No calcification was present.Purging was not carried out before the procedure.Contrast and saline were used for inflation of the balloon.It was reported that the balloon was inflated to a pressure of 8atms.It was discovered that the balloon had a slow leak and would not remain inflated.No patient injury was reported.
Additional Manufacturer Narrative
Product analysis #702508242: the device was returned in the original pouch.The label showed the catheter identification data.The data on the luer was consistent with lot number indicated in the product complaint form.A visual and tactile inspections were performed on the device.The balloon was unfolded.It was possible to insert 0,035 guidewire without any issue.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 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.
Additional 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
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7530221
• Report Number: 9612164-2018-01173
• Device Sequence Number: 1385566
• Product Code: ONU
• UDI-Device Identifier: 00643169383630
• UDI-Public: 00643169383630
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 03/15/2019
• Device Catalogue Number: ADM05012013P
• Device Lot Number: 0008536578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/13/2018; 08/08/2018
• Initial Report FDA Received Date: 05/21/2018
• Supplement Report FDA Received Date: 07/10/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1