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

Catalog Number	ADM06015013P
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
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 was attempting to use an inpact admiral with a 6fr sheath to treat a moderately calcified lesion with cto (chronic total occlusion-100%) in the mid superficial femoral artery(sfa).A 6mm spider device was used for embolic protection.An inflation device was used to inflate the balloon.Ifu was followed and the device was prepped without issue.No leaking was noted during prep of the device.It was reported that the physician encountered balloon deflation issues at the lesion site at a pressure of 8 atm.They noted that the device would not correctly hold inflation.The physician noticed contrast leaking out the back of the hub of the device.Attempts to deflate the device were not successful.The procedure was completed by slowly getting the semi inflated balloon out of the sheath.No patient injury was reported.
Additional Manufacturer Narrative
The device has been returned for evaluation.A tactile and visual inspection was performed: dried blood was found on the surface of the catheter and inside the lumen.No issue was detected at this point.During the analysis, a 0.035¿ guidewire was successfully advanced through the device.An attempt to inflate the balloon was conducted: a leak was found at the bond shaft/luer, underneath the blue strain relief.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: 7998962
• Report Number: 9612164-2018-02902
• Device Sequence Number: 13525169
• Product Code: ONU
• UDI-Device Identifier: 00643169576353
• UDI-Public: 00643169576353
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 12/07/2018

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: 01/29/2021
• Device Catalogue Number: ADM06015013P
• Device Lot Number: 0008974228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1