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

Model Number	G14809
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2022
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, an open-end flexi-tip ureteral catheter delaminated when coming into contact with a cystoscope."debris" was removed from the patient by unknown means.A new device was used to continue the procedure, and there was no further impact to the patient.Additional event and patient outcome information have been requested.
Event or Problem Description
Clarification information was received: the procedure being performed was ureteroscopy in the bladder and ureter.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.
Additional Manufacturer Narrative
Event description: as reported, during a ureteroscopy in the bladder and ureter.An open-end flexi-tip ureteral catheter delaminated when coming into contact with a cystoscope."debris" was removed from the patient by unknown means.A new device and cystoscope were used to continue the procedure, and there was no further impact to the patient.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this 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 (dhr), the instructions for use (ifu), and quality control data.One open-end flexi-tip ureteral catheter was returned for investigation.The device was returned without packaging, however the label was included confirming the lot number.A container with small shavings in it was returned that appeared to be evidence of scrapping on the catheter.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 review of manufacturing procedures was performed, including quality control procedures.Cook has concluded that sufficient inspection activities are in place to assure functionality and device integrity prior to shipping.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: if you encounter resistance while advancing or withdrawing the catheter, stop.Determine the cause of the resistance before proceeding.Do not withdraw the catheter while deflected in the cystoscope/endoscope.The complaint report indicated the catheter separated when making contact with a cystoscope.Cook has concluded the cause of the complaint is likely an unintended user error and/or contributed to the cystoscope that was used during the procedure as it was also replaced after the catheter damage was identified.Per the quality engineering risk assessment, no further action 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
• 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: 13964289
• Report Number: 1820334-2022-00491
• Device Sequence Number: 4164060
• Product Code: KOD
• UDI-Device Identifier: 00827002148093
• UDI-Public: (01)00827002148093(17)250124(10)14493605
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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: 01/24/2025
• Device Model Number: G14809
• Device Catalogue Number: 021307
• Device Lot Number: 14493605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2022
• 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
• Patient Sex: Unknown