MAUDE Adverse Event Report: COOK INCORPORATED COPE MANDRIL WIRE GUIDE; MICRO WIRE

Catalog Number G05183

Device Problem Break (1069)

Patient Problem Foreign body, removal of (2365)

Event Date 10/22/2013

Event Type  Injury  

Event Description

While performing the procedure, the micro wire caught on needle and the end of the wire broke off.The wire fragment was removed the following day.Mfr ref # 1820334-2014-00011.

• Brand Name: COPE MANDRIL WIRE GUIDE
• Type of Device: MICRO WIRE
• Manufacturer (Section D): COOK INCORPORATED; bloomington IN
• MDR Report Key: 3610825
• MDR Text Key: 4160647
• Report Number: 3610825
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: G05183
• Device Lot Number: 4502850
• Other Device ID Number: PMG-18SP-60-COPE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/22/2013
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR