MAUDE Adverse Event Report: COOK, INC. JEFFERY WIRE GUIDE; ACCESSORIES, CATHETER

Model Number JWGE-104

Device Problems Break (1069); Difficult to Insert (1316); Peeled/Delaminated (1454); Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

During percutaneous nephrolithotomy, multiple attempts to pass jeffrey wire into collecting system were unsuccessful with wire curling and stripping upon removal.On third attempt, while attempting to remove the jeffrey wire after it curled, wire stripped and broke with fragment of wire retained in the kidney but outside of the collecting system.Fda safety report id# (b)(4).

• Brand Name: JEFFERY WIRE GUIDE
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• MDR Report Key: 14934455
• MDR Text Key: 295477007
• Report Number: MW5110682
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: JWGE-104
• Device Lot Number: 14277622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White