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

Catalog Number 020015

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

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

The user facility representative reported during a cystoscopy with stent placement procedure while using the open-end ureteral catheter, a wire was inserted thru the tiger tail.When they went to pull the tiger tail out, there were black and yellow remnants like little coils in the left ureteral orifice.The procedure was already complete.At this point they went in with flexible graspers and pulled out the remnants.Nothing was left inside the patient.The tiger tail was fully intact.There were no adverse effects or consequence to the patient due to this occurrence.

Manufacturer Narrative

Corrected information: reported to regulatory agency: yes.Updated narrative: the complaint intake organization contacted the urology coordinator in confirmation of its voluntary medwatch report mw5072895.He provided information that there was no issue with the actual device not functioning.The stent placement was performed successfully.He proceeded to state that the issue seemed to have been related to the material from the device.The material remained in the patient during stent placement as if a portion of the inside of the device coiled off.After the procedure was completed, risk management was given the device for internal evaluation.An attempt to recreate the issue by inserting the guide wire used in this case and placed into a "tiger tale" device did not produce the same results.An observation revealed the wire was not stiff enough to wear away the material inside of the device.No images were available.Investigation - evaluation: a review of the complaint history, device history record, and specifications of the device were conducted during the investigation.No product was returned for evaluation.No photos were provided by the customer.Without visual, dimensional, and/or functional testing of the product, we are unable to ascertain what actually occurred.Additionally, a document based investigation evaluation was performed.There was no evidence to suggest the product was not made to specifications.A review of the device history record revealed 12 nonconforming events for lot 7997778.The non-conforming product with the surface defect was scrapped; the other non-conformances are not related to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, a definitive root cause is inconclusive.Measures have been initiated to address this failure mode.The quality engineering risk assessment for this failure mode was reviewed and it was determined that no additional risk mitigating activity is required at this time.We will continue to monitor for similar complaints.

• 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: 6854735
• MDR Text Key: 85626215
• Report Number: 1820334-2017-02866
• Device Sequence Number: 1
• Product Code: GBL
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)200616(10)7997778
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 020015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/15/2017
• Date Device Manufactured: 06/16/2017
• 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
• Treatment: WOLFE CYSTOSCOPE 21FR
• Patient Outcome(s): Required Intervention