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

Catalog Number PMG-18-80-COPE

Device Problem Tip breakage (1638)

Patient Problem Nonresorbable materials, unretrieved in body (2276)

Event Date 05/29/2014

Event Type  Injury  

Event Description

When the physician retrieved the complaint wire guide from the patient's body, he noticed that the tip of it had separated and remained in the body.As the removal of the separated segment from the body was difficult, he remained it as it was and ended the procedure.[(b)(4) 2014 new information].Left intrahepatic bile duct was punctured percutaneously and the complaint wire guide was advanced into the common bile duct.Then, a catheter was advanced over the wire guide, but feeling of strangeness was felt then.Therefore, the physician retrieved the wire guide out of the body, confirming the separation of the tip of the wire guide.The separated segment remained in the bile duct of the left lobe side.As the remained segment was difficult to retrieve, it was left as it was.The procedure itself was completed with another device.The patient's condition did not change.

Manufacturer Narrative

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

• Brand Name: COPE STAINLESS STEEL 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: 3911624
• MDR Text Key: 4514883
• Report Number: 1820334-2014-00268
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: PMG-18-80-COPE
• Device Lot Number: 4578114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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: 79 YR