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

Catalog Number	ADM06006013P
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	06/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician was using a 6x60 in.Pact admiral dcb balloon, on inflation the dcb burst at 4 atm.It should be noted that a 5mm boston mustang pta balloon also burst with one dilation due to heavy calcification within the common iliac artery.The device was prepped with no issues noted.Physician was treating a severely calcified lesion in the iliac artery with an artery diameter of 6 mm.There was no to patient or clinical sequelae.The lesion was pre dilated with a 5mm boston mustang pta balloon which also burst.The patients common ilia artery was noted to be severely calcified.No patient injury reported.

• 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: 6706443
• Report Number: 9612164-2017-00874
• Device Sequence Number: 1571092
• Product Code: ONU
• UDI-Device Identifier: 00643169383265
• UDI-Public: 00643169383265
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P140010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/14/2017

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: 08/29/2018
• Device Catalogue Number: ADM06006013P
• Device Lot Number: 0008196372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 DA