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	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The physician was attempting to use one inpact admiral balloon to treat a moderately calcified and tortuous mid right sfa plaque lesion exhibiting 75% stenosis.The device was removed from its packaging and prepped per the ifu - on inspection, no issues were noted.A non-mdt inflation device was used.The same inflation device was used successfully with other devices.The lesion was predilated.No resistance was noted when advancing the device to the lesion.It was reported that at 8atm it was noted that the balloon could not maintain pressure despite trying to constantly inflate the balloon.The physician then removed the device and completed the procedure using a non-mdt stent.Despite being unable to maintain atm pressure, the physician was happy with the vessel outcome.No patient injury was 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: 6795826
• Report Number: 9612164-2017-01110
• Device Sequence Number: 16536155
• Product Code: ONU
• UDI-Device Identifier: 00643169383265
• UDI-Public: 00643169383265
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 07/17/2017

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: 02/02/2019
• Device Catalogue Number: ADM06006013P
• Device Lot Number: 0008480648
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 59