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

Catalog Number	ADM06020013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
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
Physician was using an in.Pact admiral paclitaxel eluting balloon catheter to treat a moderately calcified lesion in the mid sfa.There was no damage noted to packaging and no issues noted when removing the device from hoop / tray.The device was prepped per ifu with no issues identified.It was reported that during balloon inflation, it burst at 9atm.All balloon fragment was removed from patient.There was no resistance encountered when advancing the device.The procedure was completed without issue once removed.There was no patient injury reported.
Additional Manufacturer Narrative
Product analysis: the inpact admiral device was returned for analysis.The device returned with blood and residue visible in the catheter and balloon material.A 0.035 inch guidewire was loaded via the distal tip and advanced through the catheter with no issues noted.Visual inspection confirmed a longitudinal tear on the distal balloon material.The tear started approximately 1.6cm proximal to the distal tip and extended for 5.8cm proximally.Lead in scratches were evident proximal and distal to the tear site.The balloon material was jagged and uneven along the length of the tear.Negative prep did not detect the presence of a leak and it was not possible to pressurize the balloon, most likely due to crystallized residue and contrast in the inflation lumen.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: a 6 fr non-medtronic sheath and a 0.035 non-medtronic guidewire were used.A non-medtronic inflation device was used to inflate the balloon.Negative prep was not performed.The procedure was completed with a new balloon of the same size as the initial balloon without issue.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: 9150335
• Report Number: 9612164-2019-04211
• Device Sequence Number: 2928882
• Product Code: ONU
• UDI-Device Identifier: 00643169975026
• UDI-Public: 00643169975026
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/08/2019

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: 09/04/2021
• Device Catalogue Number: ADM06020013P
• Device Lot Number: 0009308683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/10/2019; 11/07/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/15/2019; 11/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR