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

Catalog Number	ADM06025013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2019
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 was intending to use an inpact admiral to treat a slightly calcified plaque lesion in the mid superficial femoral artery (sfa).No embolic protection was used.There was no damage noted to the device packaging and no issues reported when removing the device from the hoop/tray.The device was prepped per ifu with no issues.The device did not pass through a previously deployed stent but resistance was encountered during advancement.It was reported that during balloon inflation to 10atm, a longitudinal balloon burst occurred.All fragments of the balloon were retrieved from the patient.Another device was used to complete the procedure.
Additional Manufacturer Narrative
Additional information: it was reported the balloon could not be inflated due to a leak at the luer product analysis: the device returned with damage visible to the luer of the device.The balloon folds were unopened and intact.It was not possible to insert 0 ,035-inch guidewire due to the presence of blood/contrast residue.The device was flushed in an effort to remove the residue build up.The guidewire still would not insert the device successfully.Negative purge did not detect a presence of a leak on the device.In order to verify the location of the leak, an attempt was made to inflate the balloon and a leak was found at the bifurcate on the luer.On initial pressurisation of the device the balloon partially inflated.At 14 atms a leak was observed from the centre of the bifurcate component.Visual inspection confirmed the presence of hairline fractures along the guidewire and balloon inflation bifurcate legs.Foreign material was visible on the guidewire lumen within the bifurcate.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: 8304516
• Report Number: 9612164-2019-00415
• Device Sequence Number: 1619694
• Product Code: ONU
• UDI-Device Identifier: 00643169975088
• UDI-Public: 00643169975088
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/27/2019

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: 09/25/2021
• Device Catalogue Number: ADM06025013P
• Device Lot Number: 0009331414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 05/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1