MAUDE Adverse Event Report: COOK INC ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE; DQX, WIRE, GUIDE, CATHETER

Catalog Number HPWAS-35-180

Device Problem Material Separation (1562)

Patient Problem Foreign body, removal of (2365)

Event Date 10/28/2013

Event Type  Injury  

Event Description

As provided on a maude report (b)(4): on (b)(6), 2013 a patient was presented with right percutaneous nephrostomy for surgical access.Several attempts were made to gain access to the kidney using a 18g x 15cm chiba access needle and a cook roadrunner uniglide stiff angle wire.The needle was wedged against a kidney stone and as the wire was advanced and withdrawn the hydrophilic coating sheared from the wire.The wire and coating were both removed from the needle and the patient with no harm to the patient.

Manufacturer Narrative

Device expiration unknown as lot is unknown.(b)(4).Event evaluation: still under investigation.

• Brand Name: ROADRUNNER UNIGLIDE HYDROPHILIC 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: 3652900
• MDR Text Key: 4193823
• Report Number: 1820334-2014-00043
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HPWAS-35-180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2013
• Distributor Facility Aware Date: 10/28/2013
• Event Location: Hospital
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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