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

Model Number	G49942
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The user facility reported during a ureterorenoscopy procedure, the physician opened the universa soft ureteral stent set and found there was a fissure at the end of the stent.The stent set was not used in the procedure.The physician used a new stent set to complete the procedure.No adverse effects or consequences were reported to the patient due to this occurrence.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the investigation included a visual inspection of the returned device, a review of complaint history, the device history record, instructions for use, and the device specifications.One 6fr 26cm stent was received.The tether has been removed from the stent and it was not returned.The proximal coil was torn starting at the first side port and continued through the end of the stent.A braided tether for repositioning and removal of the device is located on the proximal pigtail of the stent.The tether has been pulled out of the stent causing the material to tear.A review of the device history record showed there were no non-conformances.A review of complaint history revealed this is the only complaint associated with the complaint device lot number 8026821.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.There is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Based on the provided information the root cause will be attributed to product use or handling related; the product encountered excessive force.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 7116513
• Report Number: 1820334-2017-04433
• Device Sequence Number: 1669563
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)200628(10)8026821
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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 Model Number: G49942
• Device Catalogue Number: USH-626
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 12/14/2017
• Supplement Report FDA Received Date: 03/09/2018
• Patient Sequence Number: 1