MAUDE Adverse Event Report: COOK, INC. COPE MANDRIL WIRE GUIDE; DQX WIRE, GUIDE, CATHETER

Catalog Number PMG-18SP-60-COPE

Device Problem Break (1069)

Patient Problem Foreign body, removal of (2365)

Event Date 10/22/2013

Event Type  Injury  

Event Description

Information received from a user facility report indicated that 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.Additional info received 12/13/2013: the wire guide was removed from the right subclavian vein.The status of the pt is unk.No additional info has been provided by the reporter.

Manufacturer Narrative

(b)(4).Event eval: still under investigation.

• Brand Name: COPE MANDRIL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3610824
• MDR Text Key: 4170865
• Report Number: 1820334-2014-00011
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2013,12/11/2013

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: PMG-18SP-60-COPE
• Device Lot Number: 4502850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/22/2013
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2013
• Date Manufacturer Received: 12/11/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2013
• 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
• Patient Age: 70 YR