MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME OTW CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number SBI070040080

Device Problem Burst Container or Vessel (1074)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2015

Event Type  Malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The physician was attempting to treat a lesion in the left mid sfa using admiral xtreme dilatation balloon catheter. The lesion was calcified and exhibited >70% stenosis, vessel had little tortuosity. It was reported that while inflating the balloon, it only partially inflated and then burst at 6atm. Another admiral xtreme device was used and it was reported that it partially inflated and then burst. The procedure was completed using another admiral xtreme device. No patient injury or other clinical sequelae reported for this event.

• Brand Name: ADMIRAL XTREME OTW
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c.,mx
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5297059
• MDR Text Key: 34144975
• Report Number: 9612164-2015-01873
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: SZ
• PMA/PMN Number: K062809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/01/2015

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 12/15/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/31/2018
• Device Catalogue Number: SBI070040080
• Device LOT Number: 209407009
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Date Device Manufactured: 03/31/2015
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial