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

Catalog Number	ADM06006013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary a visual inspection was performed on the catheter.The balloon was found unfolded and bloodstained.It was possible to insert a 0.035¿¿ guide wire.Once positive pressure was applied, the balloon was found leaking from the proximal balloon welding.The welding was analyzed under a microscope and the hole was found.It looks like a little burst, directed from inside towards outside.
Event or Problem Description
In.Pact admiral was used as per ifu in the proximal left common femoral artery with a diameter of 7mm, to treat a 60mm long lesion with 20% stenosis , little calcification, no tortuosity or resistance encountered.Negative prep was performed with no issue noted, the lesion was pre-dilated.It was reported during the procedure the balloon was inflated slowly, at 12atm¿s a circumferential balloon burst was observed at first inflation.The device was removed from the patient over the wire all fragments were retrieved.The procedure was completed using an evercross balloon with no further issues noted.No procedural images available for review.No patient injury reported.

• 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: 6790252
• Report Number: 9612164-2017-01100
• Device Sequence Number: 103334
• Product Code: ONU
• UDI-Device Identifier: 00643169383265
• UDI-Public: 00643169383265
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 07/14/2017

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: 01/05/2019
• Device Catalogue Number: ADM06006013P
• Device Lot Number: 0008438898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 57