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

Model Number	G49941
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 reported after stent placement into the patient during an ureterorenoscopy procedure, the physician used the tether to adjust the stent position in the bladder.As reported, the universa soft ureteral stent fractured.The physician replaced the stent with another new universa soft ureteral stent to finish this procedure.No adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation 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, the instructions for use, and quality control data.Customer returned one universa soft shipping carton, labeled with part number ush-624, and lot number 8978712 for investigation.Only the stent and tether was received.Visual examination confirmed the stent was returned in two segments.Closer examination revealed the proximal coil is completely severed 6mm from first ink band and side port.The point of separation has an angle cut with mating fractures.The tether suture is still inside the proximal coil.The tether is severed at the top side of the knot.Evidence suggests the suture became wrapped around the stent during use thus cutting the stent during placement.A review of the device history records found there were no non-conformances that would have caused or contributed to the reported failure mode.A review of complaint history records revealed this complaint to be the only one associated with complaint lot number 8978712.The instructions for use (ifu) contains the following precautions: - do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.- improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.A review of the device history record was carried out and no anomalies were identified.The manufacturing processes and quality control instructions were reviewed.There were no specific issues identified with current manufacturing or quality controls that may have contributed to this incident.There have been no other complaints reported on the same lot.The complaint device was returned and the evaluation of the returned device confirmed the stent had separated at the proximal end.The tether had also separated where it is knotted, the tether was returned still attached to the stent.The separation point of the stent is not at the same location as where the tether is attached.It is possible the tether had become tangled around the stent and then cut through it when the physician was trying to reposition the stent.The stent set is supplied with instructions for use that provides precautions on forcing components.Based on the evaluation of the returned product it is possible the tether became tangled around the stent and when the physician attempted to reposition this resulted in the separation.However, a definitive conclusion for the reported issue could not be established.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
There has been no new information received since the last report was submitted.

• 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: 8257811
• Report Number: 1820334-2019-00126
• Device Sequence Number: 1914990
• Product Code: FAD
• UDI-Device Identifier: 00827002499416
• UDI-Public: (01)00827002499416(17)210626(10)8978712
• 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): 02/08/2019

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: 06/26/2021
• Device Model Number: G49941
• Device Catalogue Number: USH-624
• Device Lot Number: 8978712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70