MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Break (1069)

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

Event Date 01/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported by the user facility that a patient underwent a cytoscopy and insertion of uretic stent procedure and laser lithotripsy using an open-end flexi-tip ureteral catheter.The attending physician indicated during the insertion of the ureteric catheter it snapped within the patient.The physician retrieved the broken bits by using the grasping forceps.A second catheter was used from the same lot and it snapped as well, and the broken bits from that catheter were also removed.No unintended sections of the device remain inside the patient¿s body nor did the patient experience any additional procedures or adverse effects due to this occurrence.No further information was provided.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, , manufacturing instructions, specifications, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned devices reported thirteen unopened packages, one open empty package and one open package containing a used catheter.Used catheter was separated into 3 pieces.First point of separation occurred at 31cm, from the distal tip second separation point occurred at 31.7cm, the small segment between the severed point 7mm long, total length of catheter measured 69.8 cm.The catheter had all required ink marks indicating no missing pieces.Both severed separation points has mating fractures.During this investigation this catheter was acutely manipulated, we were unable to snapped or fracture the material.The remaining unopened devices were opened and manipulated, could not recreate incident.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6310417
• MDR Text Key: 66780328
• Report Number: 1820334-2017-00190
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)191027(10)7391626
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 021305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 DA