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

Model Number	G14809
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)
Date of Event	02/09/2021
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 jj catheter placement, using an open-end flexi-tip ureteral catheter, the flexitip catheter "crumbled'.A small end of the catheter separated and remained inside of the patient's bladder.The separated section was able to be removed with a cystoscope and forceps by the surgeon.They changed devices to complete the procedure, and there was no impact noted to the patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional patient and event information has been requested.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during a jj catheter placement, using an open-end flexi-tip ureteral catheter, the flexitip catheter "crumbled'.A small end of the catheter separated and remained inside of the patient's bladder.The separated section was able to be removed with a cystoscope and forceps by the surgeon.They changed devices to complete the procedure, and there was no impact noted to the patient.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, and quality control procedures and a visual inspection of the device were conducted during the investigation.One open-end flexi-tip ureteral catheter was returned for investigation.The overall length of the returned catheter measured 66.4cm.Material with black ink marks was shaving from the catheter starting approximately at the 25cm black ink mark and extending to the distal tip.A document-based investigation evaluation was also performed by cook.No related non-conformances were recorded, and no additional lot-related complaints were received.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the quality control procedures.Cook has concluded that sufficient inspection activities are in place to assure functionality and device integrity prior to shipping.The device is included with instructions for use which caution the following: ¿ avoid bending or kinking the catheter prior to placement.Doing so could damage the integrity of the catheter and result in patient injury.¿ if you encounter resistance while advancing or withdrawing the catheter, stop.Determine the cause of the resistance before proceeding.¿ do not withdraw catheter while deflected in cystoscope/endoscope.Based on the available information and a clinical assessment of the complaint, cook has concluded that the most probable causes of this event were unintended user error, device manipulation, and patient anatomy.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 11338825
• Report Number: 1820334-2021-00346
• Device Sequence Number: 883339
• Product Code: KOD
• UDI-Device Identifier: 00827002148093
• UDI-Public: (01)00827002148093(17)230917(10)13435859
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 09/17/2023
• Device Model Number: G14809
• Device Catalogue Number: 021307
• Device Lot Number: 13435859
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 05/10/2021
• 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: CYSTOSCOPE
• Outcome Attributed to Adverse Event: Required Intervention