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

Catalog Number	ADM05004013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2018
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-medtronic 6fr sheath and non-medtronic guidewire for treatment of a 85-90% stenosed lesion between two stents in the patients mid left superficial femoral artery (sfa).The lesion was described as being moderately calcified.No damage was noted to packaging prior to use.A non-medtronic inflation device was used.The ifu was followed during prep.Pre-dilation was carried out using a 4mm pta balloon prior to use of the in.Pact admiral without issue.It was reported that the device passed through a previously deployed stent.No resistance was encountered or excessive force used.It was reported that the balloon burst at an inflation pressure of 9atm on first inflation.The entire balloon was removed and did not fragment.No adverse event was reported.The lesion was treated with another in.Pact admiral.
Additional Manufacturer Narrative
Previously reported to fda mdr report number 2100440000-2018-8037.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: 7995858
• Report Number: 9612164-2018-02890
• Device Sequence Number: 203805
• Product Code: ONU
• UDI-Device Identifier: 00643169383609
• UDI-Public: 00643169383609
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 11/26/2018

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: 11/02/2020
• Device Catalogue Number: ADM05004013P
• Device Lot Number: 0008863385
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 11/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR