MAUDE Adverse Event Report: COOK INC FILIFORM DOUBLE PIGTAIL URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G15123
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
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 while prepping for the procedure when they took the filiform double pigtail ureteral stent out of the package it was noted the end was slit/cut.The end user department did not provide any further information as there had not been any patient contact.
Additional Manufacturer Narrative
H6 ¿ evaluation methods code: incomplete device returned (4116).Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of complaint history, the device history record, quality control data, and specifications.One 7fr 22cm black silicone stent was received.The stent was returned without the package or label to confirm the lot number of the set.The positioner and wire guide were not returned.Visual examination of the returned stent confirmed the tether was not in the stent or returned with the stent.Under magnification a tear in the proximal coil was observed.The tear starts at the first side port, located 5mm from the end of the coil, and continues through the end of the coil.The device history record review showed there were no non-conformances associated with the reported failure.A search of complaint records revealed this is the only complaint for complaint device lot number 8183360.A review of the quality control instructions identified the product is inspected before shipment.The device was returned without the manufacturing instruction specified tether.The ¿cut/slit¿ that the customer reported was confirmed.The cut starts at the first side from the tip of the proximal end of the stent.Due to the tether being removed from the coil and the appearance of the tear in the coil, it is likely the stent was torn during removal of the tether.The likely cause of the complaint; the stent was damaged when the tether was removed; cause traced to user; unintended use error caused or contributed to event.A quality engineer risk assessment concluded no risk reduction activities are required.The appropriate internal personnel have been notified and we will continue to monitor 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: FILIFORM DOUBLE PIGTAIL URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7828076
• Report Number: 1820334-2018-02621
• Device Sequence Number: 1517502
• Product Code: FAD
• UDI-Device Identifier: 00827002151239
• UDI-Public: (01)00827002151239(17)200830(10)8183360
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: 08/30/2020
• Device Model Number: G15123
• Device Catalogue Number: 133722
• Device Lot Number: 8183360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 10/09/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1