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

Model Number	G14429
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during a stent placement procedure, an open-end ureteral catheter separated.Two small device fragments remained in the patient but were successfully recovered by the surgeon.Additional event information has been requested.
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
Additional information was received 28apr2022: as reported, the separated device pieces were removed during the same procedure.The patient was not hospitalized nor was there prolonged hospitalization due to this occurrence.There were no adverse effects.
Additional Manufacturer Narrative
Additional information: b5, d9, h6: health effect - impact code (annex f) h3: device has been returned and preliminary evaluation has been performed, however, our investigation is ongoing and device evaluation summary will be included in our follow up report once our investigation has been completed.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary: as reported, during a stent placement procedure, an open-end ureteral catheter separated.Two small device fragments remained in the patient but were successfully recovered by the surgeon.The separated device pieces were removed during the same procedure.The patient was not hospitalized nor was there prolonged hospitalization due to this occurrence.There were no adverse effects.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, and quality control data.A catheter was returned as well as material from the catheter.They were returned in a specimen jar, and there were three additional pieces of material.The packaging was also returned, labelled with lot 9984139.The catheter measures 68.3 cm and the distal tip of catheter has a jagged melted appearance.(1) catheter material measures approximately 2.2 cm-distal tip is round and smooth, proximal end is jagged and has a pinched appearance (2) catheter material measures approximately 3 mm-both ends have melted appearance (3) catheter material measures approximately 1 mm-both ends have melted appearance, one side also has a slight pinched appearance a review of the device history record (dhr) found no non-conformances related to the reported failure mode.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: 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 the catheter while deflected in the cystoscope/endoscope.The catheter was returned in 3 separated points.The points of separation varied in appearance: 4 appeared melted, 1 appeared jagged and pinched, and 1 appeared melted and slightly pinched.A clinical assessment was carried out which concluded the most probable cause of this event is related to inadvertent user/procedural issues (possible difficulty with insertion/removal of device, manipulation of the device during use, etc.) and/or concomitant device use (although it is not noted that a laser, etc.Was used during the procedure, the melted appearance noted upon visual inspection indicates that the device may have inadvertently came into contact with a laser, etc.) however it was not possible to also rule out patient factors/condition.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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 information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: OPEN-END 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 ; 8128294891
• MDR Report Key: 14160683
• Report Number: 1820334-2022-00617
• Device Sequence Number: 5932230
• Product Code: KOD
• UDI-Device Identifier: 00827002144293
• UDI-Public: (01)00827002144293(17)220830(10)9984139
• 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: Other,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2022

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: 08/30/2022
• Device Model Number: G14429
• Device Catalogue Number: 020014
• Device Lot Number: 9984139
• 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: 04/05/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 05/25/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/11/2022; 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2019
• 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