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

Catalog Number	ADM05025013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/14/2019
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
The physician intended to use the inpact admiral device to treat a lesion in the mid right superficial femoral artery(sfa).The lesion was described as severely calcified with 75% stenosis, 300mm in length in an artery diameter of 5mm with moderate tortuosity.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray.The device was prepped per ifu with no issued identified.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device hence, no excessive force was used.At less than 5atm of pressure the balloon was reported to have burst on its first inflation.All fragments of the balloon were retrieved.Another balloon was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: the device returned with no damage visible.The balloon folds were open.A tactile test did not detect any kinks or abnormalities along the length of the catheter.A 0.035 inch guidewire was loaded via the distal tip and passed successfully through the device.Negative prep did not detect the presence of a leak.In order to verify the location of the leak, an attempt was made to inflate the balloon.A leak was observed from a longitudinal tear proximal to the mid balloon marker.The balloon was unable to maintain pressure.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: 8256787
• Report Number: 9612164-2019-00215
• Device Sequence Number: 11339672
• Product Code: ONU
• UDI-Device Identifier: 00643169975071
• UDI-Public: 00643169975071
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 04/26/2019

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: 07/12/2021
• Device Catalogue Number: ADM05025013P
• Device Lot Number: 0009232811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 01/14/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1