MAUDE Adverse Event Report: COVIDIEN POWERCROSS 018; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Catalog Number AB18W060060150

Device Problem Device Expiration Issue (1216)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/10/2017

Event Type  malfunction  

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 Description

The physician used one powercross balloon to treat a lesion in an unknown vessel.The device was removed from the packaging and inspected with no issues noted.The device was used successfully with no problems.It was reported that the device was used approximately one month post expiry.No patient injury was reported.

Manufacturer Narrative

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

• Brand Name: POWERCROSS 018
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6607710
• MDR Text Key: 76517842
• Report Number: 2183870-2017-00235
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00821684046869
• UDI-Public: 00821684046869
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K093286
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2017
• Device Catalogue Number: AB18W060060150
• Device Lot Number: A052147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/03/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1