MAUDE Adverse Event Report: COOK, INC. JEFFREY WIRE GUIDE EXCHANGE SET; ACCESSORIES, CATHETER

Lot Number 15109981

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  malfunction  

Event Description

Percutaneous nephrolithotomy done to the pt.He retrieved a wire guide set from interventional radiology to use for the case.When the wire was inserted, it separated from the wire sheath.Therefore, the sheath was removed, but the wire remained in the patient.The surgeon was able to locate and remove the wire from the patient.X-rays were performed intraoperatively and post-operatively to confirm that there were no retained surgical items.The patient did not sustain any injuries as a result of this incident.Device= jeffery wire guide exchange set with nitinol wire guide.Reference number: g12016, lot number: 15109981 (jwge-10-rh-nt).

• Brand Name: JEFFREY WIRE GUIDE EXCHANGE SET
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 16727958
• MDR Text Key: 313229713
• Report Number: MW5116564
• Device Sequence Number: 1
• Product Code: KGZ
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 15109981
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic
• Patient Race: White