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	04/30/2019
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
It was reported that the physician intended to use an inpact admiral balloon to treat a severely calcified, non-tortuous chronic total occlusion(cto, 100%) lesion in the mid left popliteal artery.The artery diameter and lesion length were reported to be 5 mm <(>&<)> 40 mm, respectively.There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop.A 6fr non-medtronic sheath and a 0.014 guidewire were used with no embolic protection.The device was inflated with a non-medtronic inflation device.It was reported that the balloon was inflated to 8 atm for 3 mins.The balloon was reported to have burst.All balloon fragments were retrieved.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: a leak is reported to have occurred on the hub of the device.The procedure was completed successfully using this device.The device was safely removed from the patient.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: the device returned with no damage visible to the catheter or balloon.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 with no resistance noted.Negative purge did not detect a presence of a leak on the device.The device was pressurised to 3 atms and a leak was observed from the distal part of the hub.The leak was found in the distal bonding, between the shaft and the glue fillet.The glue fillet was lifted.It was not possible to inflate the balloon.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: 8577195
• Report Number: 9612164-2019-01579
• Device Sequence Number: 1731659
• Product Code: ONU
• UDI-Device Identifier: 00643169383609
• UDI-Public: 00643169383609
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 07/04/2019

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: 09/11/2021
• Device Catalogue Number: ADM05004013P
• Device Lot Number: 0009312315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 07/03/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/22/2019; 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR