MAUDE Adverse Event Report: COOK MEDICAL ROADRUNNER HYDROPHILIC PC WIRE GUIDE

Model Number RPC-035145-0

Device Problem Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2017

Event Type  Injury  

Event Description

During utereroscopy procedure - while removing the cook medical roadrunner hydrophilic pc wire the protective coating shredded upon removal thru the scope.There is a possibility that the provider came into contact with the edge of the scope during removal.All pieces were removed and no harm to the patient.

• Brand Name: ROADRUNNER HYDROPHILIC PC WIRE GUIDE
• Type of Device: ROADRUNNER HYDROPHILIC PC WIRE GUIDE
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47404
• MDR Report Key: 6830310
• MDR Text Key: 84074452
• Report Number: MW5071826
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: RPC-035145-0
• Device Lot Number: 8066140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 43 YR