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

Model Number	G49942
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
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 area representative reported during a ureterorenoscopy procedure on a (b)(6) male patient, when the physician opened the universa soft ureteral stent it was observed that there was a fissure in the front end of the stent.Therefore, the stent was not used.The physician opened another new universa soft ureteral stent and used it to finish the procedure.There were no adverse effects or consequences to the patient due to this occurrence.
Additional Manufacturer Narrative
Additional information received: patient information; age, weight, gender.Investigation ¿ evaluation: the investigation included a visual inspection of the returned device, a review of complaint history, the device history record, documentation, instructions for use (ifu), manufacturing instructions, quality control data, and the device specifications.One open package and carton with label lot 7605018 was received.Only the stent was returned.The tether was not in the stent and it was not returned.The proximal end of the stent has a jagged tear starting at the last side port and extending through the proximal end measuring 1.5cm in length.Under magnification striations with material fibers was observed on the torn edge.There is no evidence of any manufacturing anomalies observed with the device.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.A review of the device history record showed there were no non-conformances related to the reported failure mode.A review of complaint history for this product/lot number combination revealed this is the only complaint that has been received associated with lot 7605018.This incident may be a result of a procedural related event.The stent was likely torn when removing the tether during the prepping process.The root cause has been determined to be related to product use and handling.The product received excessive pressure.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: 6995702
• Report Number: 1820334-2017-03757
• Device Sequence Number: 11101087
• Product Code: FAD
• UDI-Device Identifier: 00827002499423
• UDI-Public: (01)00827002499423(17)200119(10)7605018
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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 Model Number: G49942
• Device Catalogue Number: USH-626
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/24/2017
• Supplement Date Received by Manufacturer: 12/15/2017
• Initial Report FDA Received Date: 11/02/2017
• Supplement Report FDA Received Date: 12/19/2017
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 74