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

Model Number	G53693
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ¿ evaluation: it was reported, the proximal end of a stent from a universa soft stent set was broken.A new stent was used to complete the procedure.The stent was found broken after been removed from its package.It was reported that no additional procedures or adverse effects resulted due to this event.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, specifications, the instructions for use, and quality control data.One opened package containing a universa soft stent was returned for investigation.A visual examination confirmed the stent, stent positioner, and wire guide were returned in a prior to use condition.No damage observed on the positioner.The tether was not returned with the stent.A tear is confirmed on the stent¿s proximal coil.Closer examination revealed the tear originated at the last side port measuring 1cm long.Tear continues through end of the coil end.No other damage was found on the stent.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 manufacturing procedures found that current controls for manufacturing and quality control are in place to assure functionality and device integrity prior to shipping.The evidence from the complaint file, device history record, complaint history, quality control documents and complaint device indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions the tether should be removed if the stent is to remain indwelling longer than 14 days.The stent was returned without the tether.The instructions for use supplied with the stent set state "the tether should be removed if the stent is to remain indwelling longer than 14 days." the stent was observed to be torn.The tear was from the last side port on the proximal coil through to the tip of the stent.The tether is attached through the last sideport on the proximal coil of the stent.It was reported the damage was observed when removing the product from the packaging.The location of the damage on the stent would suggest it's related to the tether removal, however it was reported that the stent was noted to be damaged when removed from the packaging.Cook was unable to rule out shipping, manufacturing or usage as possible contributing factors to the complaint.Cook has concluded the cause of the complaint could not be established.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.The appropriate personnel will be notified and cook will continue to monitor for similar complaints.
Event or Problem Description
It was initially reported, a universa soft ureteral stent was found to broken on the proximal end after it had been removed from its package.The issue with this device was discovered prior to making contact with the patient and it was not used.A new stent was opened to complete the procedure.The device was returned 06aug2020 and it was discovered the stent was torn.It was reported that no additional procedures or adverse effects resulted 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: 10420176
• Report Number: 1820334-2020-01505
• Device Sequence Number: 11498875
• Product Code: FAD
• UDI-Device Identifier: 00827002536937
• UDI-Public: (01)00827002536937(17)220422(10)NS9686672
• Combination Product (Y/N): N
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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: No Information
• Device Expiration Date: 04/22/2022
• Device Model Number: G53693
• Device Catalogue Number: US-626
• Device Lot Number: NS9686672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1