MAUDE Adverse Event Report: COOK INCORPORATED SPIRAL TIP; CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number G14873

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/11/2017

Event Type  Injury  

Event Description

During procedure (cystoscopy with right stent insertion) after provider removed spiral tip catheter, he noticed that the spiral end of catheter was no longer intact.Provider concluded that tip of catheter still was in the patient's right ureter and could not be removed at time of procedure.Procedure was aborted.A stent wire was unable to be passed beyond the level of the stone, and a retrograde pyelogram did not demonstrate any contrast proximal to the level of the obstruction.During the procedure, the tip of a spiral-tipped catheter broke off in the right ureter and was unable to be retrieved.She subsequently went to interventional radiology for placement of a right nephrostomy tube.Specialty specific elements: distal right ureteral stone will require management/treatment.Retained foreign catheter tip in distal right ureter will require retrieval.

• Brand Name: SPIRAL TIP
• Type of Device: CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INCORPORATED; 1100 w morgan st; spencer IN 47460
• MDR Report Key: 7032472
• MDR Text Key: 92039915
• Report Number: 7032472
• Device Sequence Number: 1
• Product Code: GBL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/18/2019
• Device Model Number: G14873
• Device Catalogue Number: 024505
• Device Lot Number: 6744848
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR