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

Model Number	G14521
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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, during a cystoretrograde with stent placement procedure using a open-end flexi-tip ureteral catheter, the catheter broke off into the patient's bladder.The physician inserted the catheter, and toward the end of the procedure noticed that two pieces of the catheter had broken off into the bladder.The patient did require an additional procedure due to the occurrence.The patient was sent to interventional radiology for an antegrade nephrostogram and percutaneous ureteral stent placement.Based on hospital records, the patient was discharged.The patient had to undergo the additional and unexpected procedure as mentioned.This resulted in additional time under anesthesia.
Additional Manufacturer Narrative
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, manufacturing instructions, quality control data, and specifications.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.Visual examination confirmed a catheter was returned in used condition.The catheter was returned in two pieces.The flexible tip was separated from the distal tip, point of separation occurred above the first ink band.Length of flexible tip measures within specification tolerance of 6mm-9mm.Point of separation has occurred where the two pieces of material are bonded together.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.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.Clinical review concluded that based on the currently available information, the possible factors contributing to this situation include: patient anatomy/condition and user technique.One used open-end flexi-tip ureteral catheter was returned.The catheter was returned in two pieces.The flexible tip is separated from the distal tip where the two pieces of material are bonded together.The flexible tips length was measured and found to be in specification.The complaint was confirmed based on customer testimony and analysis of the returned device.Cook has concluded the cause cannot be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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 patient or event information has been received since the last report was submitted on 02oct2019.

• 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: 9146885
• Report Number: 1820334-2019-02519
• Device Sequence Number: 2752811
• Product Code: KOD
• UDI-Device Identifier: 00827002145214
• UDI-Public: (01)00827002145214(17)220718(10)9889867
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 12/03/2019

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: 07/18/2022
• Device Model Number: G14521
• Device Catalogue Number: 021305
• Device Lot Number: 9889867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/25/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 11 YR