MAUDE Adverse Event Report: COOK INC. WHISTLE TIP URETERAL CATHETER; CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number 022106 AND G14031

Device Problems Material Too Rigid or Stiff (1544); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2015

Event Type  malfunction  

Event Description

Patient had high cystocele and resulting bladder outflow obstruction.Surgeon performing a vaginal sling, cystocele repair.At end of procedure, the patient has already been given intravenous methylene blue; however, there was no infiltration of methylene blue within the bladder and determined the ureter was not draining and needed to be cannulated.He requested whistle tip ureteral catheter.When the doctor received catheter on sterile field he felt the catheter was too stiff to place in a possibly obstructed or kinked ureter.He was then given an open ended ureteral catheter (cook urethral dilation balloon catheter open tip) which he used for cannulation of the ureter.A limited retrograde pyelogram was performed to validate the patency of the ureter and when completed the ureter was visualized and found to have a "j hooking" shape.The doctor felt that if the whistle tip catheter would have been placed it would have perforated the ureter.He felt the problem with the cook brand catheters are too stiff and they were replaced with another brand.Manufacturer response for urethral dilation catheter, whistle tip urethral catheter 6.0fr/70cm (per site reporter): the catheter is stiff and exploring the softer options of cook catheters.

• Brand Name: WHISTLE TIP URETERAL CATHETER
• Type of Device: CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC.; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5131067
• MDR Text Key: 27631809
• Report Number: 5131067
• 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: Nurse
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: 022106 AND G14031
• Device Catalogue Number: 022106 AND G14031
• Device Lot Number: 5365739
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 74