MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G49941
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary of event: as reported, upon opening a universa soft ureteral stent set, the stent was broken between the two side ports on one end.The tether was also attached to the stent.A new device was used to complete the procedure.No section of the device remained inside the patient's body.No additional procedures required due to the occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.Investigation evaluation: reviews of the complaint history, device history record, documentation, instructions for use (ifu), and quality control procedures were conducted during the investigation.An interview with personnel was also conducted.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest this device was manufactured out of specification.No pictures were provided of the broken stent.A review of the device history record found no non-conformances related to the reported failure mode.A complaint history search of complaints associated with this lot revealed one additional customer complaint (cook complaint reference number - 338917).The stent for this complaint was returned and through inspection it was concluded that unintended user error was the root cause.Therefore, due to these findings, it can be concluded that the presence of this additional customer complaint does not indicate a systemic issue with the lot.The product's instructions for use (ifu) includes the following related to the reported failure mode: precautions.The tether should be removed if the stent is to remain indwelling longer than 14 days.How supplied? upon removal from package, inspect the product to ensure no damage has occurred.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A cause for the reported break in the stent was unable to 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.
Event or Problem Description
As reported, upon opening a universa soft ureteral stent set, the stent was broken between the two side ports on one end.The tether was also attached to the stent.A new device was used to complete the procedure.No section of the device remained inside the patient's body.No additional procedures required due to the occurrence.The complainant has not reported any adverse effects on the patient due to this occurrence.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12700688
• Report Number: 1820334-2021-02391
• Device Sequence Number: 4703507
• Product Code: FAD
• UDI-Device Identifier: 00827002499416
• UDI-Public: (01)00827002499416(17)240105(10)13667325
• Combination Product (Y/N): N
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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: 01/05/2024
• Device Model Number: G49941
• Device Catalogue Number: USH-624
• Device Lot Number: 13667325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1