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 Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
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
It was reported, the flexi-tip of an open-end flexi-tip ureteral catheter came off of the rest of the catheter.No adverse events have been reported as a result of the alleged malfunction.Additional information has been requested regarding the patient and the event.At the time of this report, no further information has been provided.
Additional Manufacturer Narrative
Additional information: h6 patient code.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.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
Additional information was received 21jan2021.The procedure being performed was a retrograde ureteroscopy.The issue with this device was discovered prior to making contact with the patient.No section of the device remained inside the patient or had to be removed from the patient.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects to the patient due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: it was reported that the flexi-tip of an open-end flexi-tip ureteral catheter came off the rest of the catheter during a retrograde ureteroscopy.This was discovered prior to contacting the patient.No section of the device remained inside the patient or had to be removed from the patient.The patient did not require any additional procedures due to this occurrence.The complainant has not reported any adverse effects to the patient due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examination was performed.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.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 controls are in place to assess the tensile strength of the catheter.The device is included with instructions for use which caution, ¿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, cook has concluded that a cause for the reported issue could not be established.Cook will continue monitoring of similar complaints and have 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: 11037761
• Report Number: 1820334-2020-02336
• Device Sequence Number: 19159495
• Product Code: KOD
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)231012(10)13483887
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 13483887
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 01/21/2021; 04/06/2021
• Initial Report FDA Received Date: 12/18/2020
• Supplement Report FDA Received Date: 01/27/2021; 04/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1