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

Catalog Number PMG-18SP-60-COPE

Device Problem Tip breakage (1638)

Patient Problem Foreign body, removal of (2365)

Event Date 02/28/2014

Event Type  Injury  

Event Description

Info from maude report ((b)(4)) indicated that on(b)(6) 2014 during initial access of a cardiac catheterization of the artery using a micro puncture needle and wire set, the tip of the wire was shaved off and left in pt.Using another product and company equivalent, the same event happened and a second tip was shaved off and left in the pt.Shaved off portion of devices were surgically removed.

Manufacturer Narrative

(b)(4).This device is inspected 100% for bends, kinks, adequate joint strength and other surface imperfections prior to transport.In additional each pmg wire guide comes with an attached caution label which illustrates; "withdrawal and/or manipulation of the distal spring coil portion of the wire guide through the needle tip may result in breakage".No product was returned to assist in the investigation.In previous complaints we have found possible causes to include damage to the wire guide associated with withdrawal through the needle or other instrument.Root cause is did not follow instruction/label.We have notified appropriate internal personnel and continue to monitor complaints for similar events.No additional actions required at this time.Per qera, additional action is not required at this time based on the associated risk.

• 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, dir ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3817593
• MDR Text Key: 20717435
• Report Number: 1820334-2014-00182
• 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: Other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: PMG-18SP-60-COPE
• Device Lot Number: 4718949
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2013
• Distributor Facility Aware Date: 02/28/2014
• Device Age: 1 MO
• Event Location: Hospital
• Date Manufacturer Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2014
• 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