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

Model Number	G14274
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: or manager.Pma/510k # k171662.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 that during an extracorporeal shock wave lithotripsy (eswl), a open-end ureteral catheter was being removed from the ureter when it broke into two pieces.The physician removed the broken portion of the device from the patient using reusable graspers.It is unknown how the procedure was completed after the section of the device was removed.It was reported that no portion of the device remained within the patient.The patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation.It was reported, following extracorporeal shock wave lithotripsy, the catheter was being removed when it was discovered to have broken in half.The pieces were successfully retrieved with graspers.There was no harm to the patient as a result of the event.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, specifications, and quality control data.One device was returned for investigation.A visual examination confirmed a 5 fr catheter was returned in a used condition and separated in two segments.The catheter was severed 21.2cm from the distal tip, approximately 5mm from the 21st ink band.The proximal segment measured 47.7cm.Total catheter length returned was 68.9cm.The point of separation had mating fractures with dark debris on the edges.The point of separation had white stress marks on the inside wall and edge indicating the catheter was bent or pinched and severed.A review of the device history record(dhr) 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 field.There is no indication that a design process or related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Based on information received from the reporting facility, evaluation of the returned complaint device, and inspection controls in place, the cause for the reported failure mode is attributed to damage due to mishandling during use.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.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.
Event or Problem Description
There is no new patient or event information to report.

• Brand Name: OPEN-END URETERAL CATHETER
• Common Device Name: KOD CATHETER, UROLOGICAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 9785211
• Report Number: 1820334-2020-00540
• Device Sequence Number: 2650302
• Product Code: KOD
• UDI-Device Identifier: 00827002142749
• UDI-Public: (01)00827002142749(17)221018(10)10092980
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2020

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: 10/18/2022
• Device Model Number: G14274
• Device Catalogue Number: 020015
• Device Lot Number: 10092980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1