MAUDE Adverse Event Report: COOK, INC. HIWIRE NITINOL HYDROPHILIC WIRE GUIDE

Catalog Number HW-035150

Device Problem Wire(s), breakage of (2347)

Patient Problem Foreign body, removal of (2365)

Event Date 03/06/2014

Event Type  Injury  

Event Description

A patient underwent a ureteroscopy on (b)(6) 2014.The wire broke off inside the patient's ureter.The wire was removed and the piece that broke off was retrieved.No pieces of the device remained inside the patient's body.A new device was opened and used to complete the procedure.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

• Brand Name: HIWIRE NITINOL HYDROPHILIC WIRE GUIDE
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 3763374
• MDR Text Key: 4466643
• Report Number: 1820334-2014-00138
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: HW-035150
• Device Lot Number: 10245647
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/10/2014
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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