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

Model Number	G49933
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
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
It was reported during a ureteroscopy and laser stone fragmentation (ursl) procedure while using the universa soft ureteral stent set the physician found the pusher had broken.As reported, he used another new universa soft ureteral stent set to finish this medical procedure and without difficulties.Additional information has been requested concerning the patient and event.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a visual inspection of the returned device was conducted.A document based investigation was performed including a review of complaint history, the device history record, instructions for use, and device specifications.One opened package labeled rpn ush-524 with label lot number 8356240 was received.The sealed wire guide pouch and one open stent pouch containing the stent and positioner were returned.Visual examination of the components confirmed the positioner was kinked in three locations starting from the distal tip.The kinks were observed at 15.5cm, 24cm and 25.3cm.Positioner was wired using a hsf-035-50-qc wire guide.The wire was snug during transition through the kinked areas.The complaint was confirmed based on the visual examination of the product.A review of the device history record noted there were no non-conformances identified on this lot.A search of complaint records revealed this is the only complaint associated with complaint lot number 8356240.As found in the universa soft ureteral stents instructions for use (ifu): how supplied: upon removal from package, inspect the product to ensure no damage has occurred.Based on the evidence presented by the sample it is possible that the damage to the positioner occurred during shipping or storage of the finished product.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.
Event or Problem Description
There has been no new information received since the last report was submitted on 11jul2018.

• 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: 7678534
• Report Number: 1820334-2018-02048
• Device Sequence Number: 19201171
• Product Code: FAD
• UDI-Device Identifier: 00827002499331
• UDI-Public: (01)00827002499331(17)201107(10)8356240
• Combination Product (Y/N): N
• 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): 08/29/2018

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: Health Professional
• Device Expiration Date: 11/07/2020
• Device Model Number: G49933
• Device Catalogue Number: USH-524
• Device Lot Number: 8356240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/29/2018
• Patient Sequence Number: 1