MAUDE Adverse Event Report: COOK, INC. HIWIRE NITINOL CORE GUIDEWIRE 0.35" /150 CM; ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number HWS-035150

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/27/2020

Event Type  malfunction  

Event Description

Guidewire tip broke off and was retained in pt's bladder post procedure.Pt passed tip while voiding without harm or intervention.Patient had a bilateral laser lithotriisy with ureteral stent placement and was discharged to home same day without complications.The following day the patient presented lo the emergency department (ed) after urinating out a "small plastic tube", per the patient.The item was identified as a piece of the guidewire tip that was used during the procedure.The device is used on average 70 times per week at this facility without incident.Recommend the company change the color of the guidewire tip to differentiate the tip from the guidewire itself.The current guidewire and tip is all black in color, so defect are hard to identify post procedure.

• Brand Name: HIWIRE NITINOL CORE GUIDEWIRE 0.35" /150 CM
• Type of Device: ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 10785238
• MDR Text Key: 214779973
• Report Number: MW5097628
• Device Sequence Number: 1
• Product Code: OCY
• 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: 10/30/2020

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 Model Number: HWS-035150
• Device Catalogue Number: G30474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 YR