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

Catalog Number	ADM06012013P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the device was returned in its original pouch and box.The data on the luer is consistent with lot number indicated in the product complaint form (lot# 0008615572).Visual and tactile inspections were performed on the device: traces of blood were found on the device.The balloon was found unfolded.The guide wire lumen was flushed and a 0,035¿¿ guide wire was successfully advanced through the device.Negative pressure was applied to the balloon: the purging procedure failed.Positive pressure was applied to the balloon, in order to identify the problem: a leakage was noted on the shaft, at 13cm from the strain relief.It was not possible to inflate the balloon.A microscope was used to better identify the leak on the shaft.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use an in.Pact admiral paclitaxel-eluting pta balloon catheter for the treatment of a moderately calcified plaque lesion in the superficial femoral artery.Ifu was followed.Device prepped without issue.Embolic protection was used.Inflation device was used.It was reported that there was a hole in the delivery catheter shaft that was realized upon initial inflation at a pressure of 8 atm.Device was replace with another dcb and angioplasty was completed.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: 7177617
• Report Number: 9612164-2018-00039
• Device Sequence Number: 1212049
• Product Code: ONU
• UDI-Device Identifier: 00643169859975
• UDI-Public: 00643169859975
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/09/2018

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: 05/11/2019
• Device Catalogue Number: ADM06012013P
• Device Lot Number: 0008615572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2017
• Initial Report FDA Received Date: 01/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR