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	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Occupation- or manager device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.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 ureteroscopy procedure, an open-end flexi-tip ureteral catheter separated.When the device was placed, the physician encountered resistance.When checked with fluoroscopy, it was noted that the device had separated approximately halfway along the device.An ncircle stone extractor was used to retrieve the separated fragment.The procedure was continued and completed as intended with no further complications.A section of the device did not remain inside the patient¿s body.The patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during a ureteroscopy procedure, an open-end flexi-tip ureteral catheter separated.When the device was placed, the physician encountered resistance.When checked with fluoroscopy, it was noted that the device had separated approximately halfway along the device.An ncircle stone extractor was used to retrieve the separated fragment.The procedure was continued and completed as intended with no further complications.A section of the device did not remain inside the patient¿s body.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, quality control procedures and visual inspection were conducted during the investigation.One open-end flexi-tip ureteral catheter was returned for investigation.The device was returned in two segments.The distal segment measured approximately 26.1 cm.The segments appeared to be mating fractures.A wire guide was passed through both segments successfully.A document-based investigation evaluation was performed.No related nonconformances were recorded, and there have been no other lot-related complaints 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.A review of relevant manufacturing documents was conducted.No gaps were discovered during reviews of the device manufacturing instructions or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The instructions for use provided with the device state 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.¿ ¿upon removal from the package, inspect the product to ensure no damage has occurred.¿¿ based on the available information, cook has concluded as specific cause for the complaint cannot be established.Based on the information provided, inadvertent user error, patient anatomy, and device failure could not be ruled out as possible causes.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.

• 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: 11695163
• Report Number: 1820334-2021-01175
• Device Sequence Number: 14198274
• Product Code: KOD
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)230318(10)13064219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/26/2021

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: 03/18/2023
• Device Model Number: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 13064219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Initial Date Received by Manufacturer: 04/02/2021
• Supplement Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 07/27/2021
• 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 URETEROSCOPE; STORZ URETEROSCOPE
• Outcome Attributed to Adverse Event: Required Intervention