MAUDE Adverse Event Report: COOK INC C-FLEX MULTI-LENGTH URETERAL STENT SET; FAD, STENT, URETERAL

Model Number	G15532
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a stent insertion procedure, when the surgeon attempted to insert the c-flex multi-length ureteral stent set, she noted that it felt "different" to normal.The stent was found to be brittle and broke easily in her fingers.Another stent with a different lot number was used to complete the procedure.No section of the device remained inside the patient's body.There were no adverse effects on the patient due to this occurrence.
Additional Manufacturer Narrative
E1: phone: (b)(6).H3: device evaluation anticipated, but not yet begun.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
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Information received 03sep2025 stating the device was found and would be returned: d9: device available for evaluation h3: device evaluation anticipated, but not yet begun.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 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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Additional information: d4- primary udi number, d9 - device available for evaluation correction: d8: device was not serviced by a third party was indivertibly left out in initial mdr.Investigation evaluation: description of event: it was reported during a stent insertion procedure, when the surgeon attempted to insert the c-flex multi-length ureteral stent set, she noted that it felt "different" to normal.The stent was found to be brittle and broke easily in her fingers.Another stent with a different lot number was used to complete the procedure.No section of the device remained inside the patient's body.There were no adverse effects on the patient due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), quality control procedures, manufacturing instructions (mi), and instructions for use (ifu), were conducted during the investigation.The customer indicated the product was unavailable for return to cook for examination.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.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 related complaints associated with device lot.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 lot related complaints that have been received from the field, it was concluded that that the device was manufactured to specification and there is no evidence that nonconforming product exists in house or in the field.The device was supplied with ifu which includes the following precautions improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.Angulation of the wire guide or stent should be avoided.Cook has concluded a definitive cause could not be determined.The appropriate personnel have been notified and cook will continue to monitor for similar events.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.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d9 - device available for eval: no.H3 ¿ the device is not being returned for evaluation.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 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: C-FLEX MULTI-LENGTH URETERAL STENT SET
• Common Device Name: FAD, STENT, URETERAL
• 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 ; 8123392235
• MDR Report Key: 22298312
• Report Number: 1820334-2025-00739
• Device Sequence Number: 20989822
• Product Code: FAD
• UDI-Device Identifier: 00827002155329
• UDI-Public: (01)00827002155329(17)251121(10)15082788
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K162104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/05/2026

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: 11/21/2025
• Device Model Number: G15532
• Device Catalogue Number: 036300
• Device Lot Number: 15082788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 08/25/2025; 09/03/2025; 12/18/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/26/2025; 10/01/2025; 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2022
• 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
• Patient Sex: Unknown