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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an unknown procedure, an open-end flexi-tip ureteral catheter broke during use.A ureteroscopy had to be performed to retrieve the broken piece successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Initial reporter: occupation: inventory coordinator.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
Additional Manufacturer Narrative
Event summary: it was reported that during an unknown procedure, an open-end flexi-tip ureteral catheter broke during use.A ureteroscopy had to be performed to retrieve the broken piece successfully.A section of the device did not remain inside the patient¿s body.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.Investigation - evaluation: a document-based investigation was performed including a review of complaint history, device history record (dhr), quality control data, and the instructions for use (ifu).The complaint device was not returned; therefore, no physical examinations could be performed.A review of the device history record found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: 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.A review of the device history records found no anomalies and no other complaint have been reported for the lot.A review of manufacturing procedures found controls to be in place to assure functionality and device integrity prior to shipping.Based on the limited information surrounding the event a cause for the complaint could not be established it was not possible to rule out inadvertent user/procedural issues.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database 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.
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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15043386
• Report Number: 1820334-2022-01224
• Device Sequence Number: 6929690
• Product Code: KOD
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)250420(10)14680146
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: 04/20/2025
• Device Model Number: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 14680146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/13/2022
• Supplement Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 07/18/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown