MAUDE Adverse Event Report: COOK, INC. SET, PERCUTAN ACCESS NEFF 7F 20C NEPHROURETEROSTOMY TUB PLACEMENT KIT; ACCESSORIES, CATHETER

Model Number G08426

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/26/2021

Event Type  Injury  

Event Description

During a surgical procedure for place nephroureteral cath perc left the guide wire tip was broken in the kidney, due to an unknown barrier.Attempts were made to remove without success, evidenced by x-ray.Initial guide wire was removed, and a new guide wire used to continue the procedure.Also noted that on (b)(6) 2021 an x-ray confirmed indicated that wire fragment was no longer seen on x-ray.Fda safety report id # (b)(4).

• Brand Name: SET, PERCUTAN ACCESS NEFF 7F 20C NEPHROURETEROSTOMY TUB PLACEMENT KIT
• Type of Device: ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 12738010
• MDR Text Key: 279988460
• Report Number: MW5105070
• Device Sequence Number: 1
• Product Code: KGZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G08426
• Device Lot Number: 14058133
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 72 YR
• Patient Weight: 90