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

Model Number	G49977
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: regional purchasing manager.Investigation: evaluation: reviews of the device history record, complaint history, manufacturing instructions, and quality control data were conducted during the investigation.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 the product was not made to specifications.A review of complaint history records shows no other complaints associated with the complaint device lot.A review of the reported lot number identified that all product had been shipped to customers by 21jun2019.A review of complaint history records for the universa soft product line (ush prefix) was carried out to find similar failure modes.No other customer had reported a failure of the lining, however other customers had reported a crack occurring in the stent.Of those complaints, the ones that had used device returns all had the same findings.The stent was found to have a tear at the same sideport as the tether was attached (the devices were returned without a tether).The cause of these failures could not be established.This will be considered the failure mode for this complaint in the absence of other information from the customer or a returned device.Based on the information provided and no product returned, investigation has concluded that a cause for the complaint could not be established.The stent was assumed to be torn based on the available information and reviewing complaints with similar descriptions.The review of production processes, quality inspection documentation and the device history records did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.Per the quality engineering risk assessment no further action is required.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.
Event or Problem Description
It was reported, prior to a ureteroscopy with a stent placement procedure, a universa soft ureteral stent set was inspected, and upon inspection it was found that there was a crack in the lining.This was found before it made patient contact.Another universa soft ureteral stent set was opened and used to complete the procedure.No adverse effect to the patient was reported due to this event.

• 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: 8911746
• Report Number: 1820334-2019-02048
• Device Sequence Number: 19521231
• Product Code: FAD
• UDI-Device Identifier: 10827002499772
• UDI-Public: (01)10827002499772(17)220507(10)9720642
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• 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
• Report Date (Section B): 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 05/07/2022
• Device Model Number: G49977
• Device Catalogue Number: USH-600-R
• Device Lot Number: 9720642
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR