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

Model Number	G49941
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
Prior to an unknown ureteral procedure, a physician tested a universa soft ureteral stent set and found a "crease" near a sideport.The physician decided that due to this issue the stent should not be used to carry out the procedure.To complete the procedure another universa soft ureteral stent set was opened.No adverse effects to the patient have been reported due to this event.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of device history record, the instructions for use, and specifications.One device was returned for investigation.The returned packaging confirms the reported complaint device lot number.A visual exam of the returned device confirmed a tear in the material on the proximal coil.Closer examination revealed that the tear originated at the last side port and measured 1cm long.The tear continues through the end of the coil.No other damage was noted on the stent.The stent was damaged during tether removal.A review of the device history record found no non-conformances related to the reported failure mode.As 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 complaints have been received from the field for lot 9359602, it was concluded that there is no evidence that nonconforming product exists in house or in field.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 cause of the complaint could not be established.The returned stent had a tear 1cm in length that was between the tip of the stent and the side port where the tether was originally attached to the stent.The stent was returned without a tether, it is possible the stent was damaged removing the tether.The tether, side ports and tips of the stent are inspected as part of final inspection of the stent.The lot records for the device has no related anomalies and no other complaints have been reported for the same failure mode.Most probable cause of this event has been contributed to rigorous handling of the device in a clinical setting.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and 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 on 23aug2019.

• 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: 8925628
• Report Number: 1820334-2019-02099
• Device Sequence Number: 268811
• Product Code: FAD
• UDI-Device Identifier: 00827002499416
• UDI-Public: (01)00827002499416(17)211205(10)9359602
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2019

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: 12/05/2021
• Device Model Number: G49941
• Device Catalogue Number: USH-624
• Device Lot Number: 9359602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/23/2019
• Supplement Report FDA Received Date: 09/23/2019
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 73