MAUDE Adverse Event Report: COOK INC OPEN-END FLEXI-TIP URETERAL CATHETER; KOD CATHETER, UROLOGICAL

Model Number	G14521
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a cystoscopy using a open-end flexi-tip ureteral catheter, the end of the catheter separated.The separated part was retrieved with cystoscopic graspers.There was no difficulty advancing or withdrawing the catheter.The procedure was successfully completed with another device of the same type.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.
Event or Problem Description
There is no new patient or event information to report.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event description: as reported, during a cystoscopy using a open-end flexi-tip ureteral catheter, the end of the catheter separated.The separated part was retrieved with cystoscopic graspers.There was no difficulty advancing or withdrawing the catheter.The procedure was successfully completed with another device of the same type.No unintended section of the device remained inside of the patient's body.No additional procedures were required due to the occurrence.No adverse effects were reported due to the occurrence.Investigation ¿ evaluation.A visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, and quality control data.One open-end flexi-tip ureteral catheter was returned for investigation in three segments.The distal tip measured 4 mm.The distal end measured 5 mm.The proximal segment measured 69.5 cm.The points of separation appeared to match.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there were no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in the field.A device master record review was performed, including quality control procedures.Cook has concluded that sufficient controls are in place to assure the catheter's integrity prior to shipment.The instructions for use (ifu), provides the following precautions to the user related to the reported failure mode: ¿ avoid bending or kinking the catheter prior to placement.Doing so could damage the integrity of the catheter and result in patient injury.There is no information on how the device was prepared prior to use.How the device was prepped prior to the procedure could have contributed to damage to the catheter and causing separation upon use.¿ if you encounter resistance while advancing or withdrawing the catheter, stop.Determine the cause of the resistance before proceeding.The operator denied any difficulty with advancement or withdrawal of the catheter.If there was resistance encountered it is probable this could have contributed to separation.At this time cook could not rule out product handling, medical procedure and device failure as possible causes.Cook has concluded a cause for the complaint cannot be established.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The appropriate personnel have been notified, and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: OPEN-END FLEXI-TIP URETERAL CATHETER
• Common Device Name: KOD CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11373276
• Report Number: 1820334-2021-00388
• Device Sequence Number: 11700717
• Product Code: KOD
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)231124(10)13586729
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K171662
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 13586729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STORZ CYSTOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention