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

Model Number	G49942
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was originally reported prior to a ureteroscopy using a universa soft ureteral stent set for the procedure, the physician tested the product and found that there was a "crease" on the side of the drainage hole.This device was not used.A new stent set was opened to complete the procedure.This event is not reportable.No adverse effects to the patient have been reported as a result of this occurrence.Upon evaluation of the returned complaint device it was found by the manufacturer that the device had a split that originates from the side-port whether the tether is specified to be attached.The device was returned without the tether.
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.Investigation ¿ evaluation reviews of the complaint history, device history record, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned package confirmed that one universal soft ureteral stent set was returned for investigation.Only the stent was received, the tether was no included.The first sideport on the distal coil was split starting on the edge of the port.The proximal coil was intact and undamaged.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the specifications and quality control procedures were conducted, and no gaps were discovered.Moreover, an ifu is provided with this device, which states the device should be ¿store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided and the examination of the returned product, investigation has concluded that a root cause for this event could not be established.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.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.

• 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: 8696061
• Report Number: 1820334-2019-01390
• Device Sequence Number: 11413173
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)210906(10)9145036
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2019

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: 09/06/2021
• Device Model Number: G49942
• Device Catalogue Number: USH-626
• Device Lot Number: 9145036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 57