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	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2017
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
Physician intended to use an impact admiral paclitaxel-eluting pta balloon with a non-mdt 6fr sheath, non-mdt.035" guidewire and 6mm spider fx embolic protection device for the treatment of a moderately calcified lesion in the mid superficial femoral artery (sfa).Lesion exhibited 85% stenosis.Vessel reported to be moderately tortuous.A non-mdt inflation device was used.Ifu was followed and device prepped without issue.It is reported that at a pressure of 2atm, the balloon burst during balloon inflation.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.All fragments were retrieved.Another dcb was opened to complete procedure without further issue.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation summary: the device was returned for evaluation.A visual and tactile inspections were performed on the device.The balloon was unfolded and dirty of blood.It was not possible to insert 0 ,035 guidewire because the guide wire lumen was full of hardened blood.Flushing the guide wire lumen it was observed the solution coming out from the inflation port of the hub.The purging procedure was performed, but revealed a leak, since the bubble flow under negative pressure did not stop.In order to verify the point of leak, an attempt was done to inflate the balloon and the inflation solution went out from the guide wire lumen port.The luer was magnified using a microscope and a burst was found in the tubes welding near the hub.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: 7233338
• Report Number: 9612164-2018-00181
• Device Sequence Number: 19362117
• Product Code: ONU
• UDI-Device Identifier: 00643169576353
• UDI-Public: 00643169576353
• 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,Followup
• Report Date (Section B): 02/26/2018

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: 08/10/2019
• Device Catalogue Number: ADM06015013P
• Device Lot Number: 0008733090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 02/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 91