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

Model Number	G23367
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Motion guide wire, unknown grasper, unspecified scope.Occupation: director.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 is reported, during a right cysto laser lithotripsy procedure using a universa soft ureteral stent set, the tether broke.It was provided that when the physician placed the stent with the tether attached to stent, the tether broke as she began pulling out the scope.The physician retrieved the stent and tether without issue using an unknown "grasper," and placed another similar device.The patient experienced no adverse effects as a result of this alleged product malfunction.The patient did not require any additional procedures as a result of this occurrence.
Additional Manufacturer Narrative
(b)(4).Investigation evaluation: a visual inspection and functional testing 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(ifu), manufacturing instructions, and quality control data.Device failure analysis: the complainant returned one used universa soft stent for investigation.Visual examination confirmed sent and tether returned in used condition.Tether is severed 15.5cm from the knot, knot was still intact.Remaining 32cm of tether still attached to the proximal coil at the first sideport.Tether did not appear elongated or stretched out of shape.Severed ends have a straight cut appearance.No manufacturing anomalies observed on the device.Device history record review for this lot showed no nonconformances related to the reported failure.A review of complaints showed that there are no other related complaints for this lot.Furthermore, reviews of the manufacturer¿s instructions and quality control procedures were conducted, and no gaps were discovered.Conclusion: the cause of the complaint could not be established.The returned device analysis identified the tether appeared severed and was not stretched or elongated.It is possible that a another device used in the same procedure contributed to the complaint by cutting through the tether, the scope was being removed from the patient when the tether was broken.The risk analysis was conducted and concluded no additional risk reduction was required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.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
No new patient or event information to report.

• 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: 8692538
• Report Number: 1820334-2019-01397
• Device Sequence Number: 1858008
• Product Code: FAD
• UDI-Device Identifier: 10827002233673
• UDI-Public: (01)10827002233673(17)220313(10)9588736
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: 03/13/2022
• Device Model Number: G23367
• Device Catalogue Number: USH-524-RT1
• Device Lot Number: 9588736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Initial Date Received by Manufacturer: 05/28/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1