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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that while performing a cystoscopy, left stone manipulation procedure, the surgeon placed ¿open-end ureteral catheter¿ into the patient.Near the conclusion of the procedure, the surgeon noticed that the distal end of the catheter had broken off.The surgeon was able to retrieve the retained catheter with help of graspers.No unintended section of the device remained inside the patient¿s body.No additional information has been provided at this time.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, dimensional verification, device history record, manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device reported one open package for returned.Partial catheter only returned approximately 7.3cm of catheter¿s distal end has been severed and not returned.Proximal segment measured 61.6cm.Based on ink band increments, catheter measured 68.9cm indicating measurement within specification prior to being severed.This catheter segment had the 050010 adapter tightened down on the proximal end.Point of separation had a pinched appearance and has been cut at an angle.This device appears to have been damaged by an instrument of unknown origin.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 an the results of our investigation, the failure happened inside the patient and patient needed additional procedure to remove the broken pieces.The product was returned for evaluation and the complaint is confirmed based on the investigation of the returned product.As per the evaluation, this failure is likely happened by some unknown instrument used in this procedure.The root cause is likely to be product use or handling caused by another device.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: OPEN-END URETERAL CATHETER
• Type of Device: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6533815
• MDR Text Key: 74064402
• Report Number: 1820334-2017-00784
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)190818(10)7207955
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• 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: 020015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• 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