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

Catalog Number SBI070040130

Device Problem Device Expiration Issue (1216)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/27/2017

Event Type  Injury  

Event Description

Physician used admiral xtreme to treat a calcified lesion in the sfa.Procedure was completed successfully.It was reported that the device was used approximately 1 month post expiry.The patient was placed on antibiotics.No further sequelae reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ADMIRAL XTREME OTW
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6517818
• MDR Text Key: 73557384
• Report Number: 9612164-2017-00492
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K062809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: SBI070040130
• Device Lot Number: 207996340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Date Device Manufactured: 02/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention