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

Catalog Number PMG-18-60-COPE

Device Problems Material Separation (1562); Unraveled Material (1664)

Patient Problems Foreign body, removal of (2365); Surgical procedure, additional (2564)

Event Date 07/02/2014

Event Type  Injury  

Event Description

On the (b)(6) 2014, a cope stainless steel mandril wire guide was used combined with another manufacturer's 21g trocar needle during procedure of nephrostomy.The wire guide was advanced through the trocar to the site where stone was confirmed.When the wire guide was being withdrawn, the physician noticed breakage of the wire guide; the soft tip got separated and remained in the patient body.(coil of the broken wire guide was unravelled).On (b)(6) 2013 additional information received from the rep indicated that on the (b)(6) 2014, the pnl procedure that was originally scheduled to be conducted on (b)(6) 2014 was performed as planned.During the procedure, the remained segment of the wire guide was removed together with crushed stone.There have been no adverse effects to the patient reported.

Manufacturer Narrative

(b)(4).Event is still under investigation at this time.

• Brand Name: COPE STAINLESS STEEL MANDRIL WIRE GUIDE
• Type of Device: DQX WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47402
• Manufacturer Contact: rita harden, dir. ; 750 daniels way; bloomington, IN 47402 ; 8123392235
• MDR Report Key: 4017580
• MDR Text Key: 4848271
• Report Number: 1820334-2014-00335
• 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: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: PMG-18-60-COPE
• Device Lot Number: F4341650
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/15/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Manufacturer Received: 07/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2013
• 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