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

Model Number	G15145
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Pma/510(k) #: preamendment.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 the physician planned to replace the patient¿s ureteral stent.When opening the package containing the filiform double pigtail ureteral stent set, the user found one end of the stent was broken.Further clarification was received advising that the stent was cracked but it was still together.The stent was not used.A new stent was opened and used to complete the procedure.There were no adverse consequences to the patient as a result of this reported issue.The device was not used.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of complaint history, the device history record, and specifications was performed.A visual examination of the returned stent was also conducted.One open package rpn, label lot 8344354 was received.Stent, positioner and wire guide inside the holder were returned inside the packaging tray.The stent was returned without the tether.The proximal coil has a jagged tear starting at the first side port continuing through the end.There is no indication that a design or process related failure mode contributed to this event.A review of the device history record found no non-conformances related to the reported failure.A review of complaint history for this product/lot number combination did not reveal any other complaints to be associated with the complaint device lot 8344354.Stent material was torn during tether removal.Based on the information provided and returned device analysis, it is possible the cause of this failure is related to the way in which the product was handled.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: 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: 7354880
• Report Number: 1820334-2018-00798
• Device Sequence Number: 1393300
• Product Code: FAD
• UDI-Device Identifier: 00827002151451
• UDI-Public: (01)00827002151451(17)201102(10)8344354
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2018

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 Model Number: G15145
• Device Catalogue Number: 133624
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/23/2018
• Patient Sequence Number: 1