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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem Description
It was reported that a (b)(6) male patient had a stent placed in (b)(6) 2015.After several months, the stent was found to be surrounded by calculus.Thus, the stent was removed in late (b)(6) 2016.The patient had cystolith when reviewing after the procedure.The surgeon operated using the pneumatic lithotripsy under ureteroscope.The stent detached while removing.The user took an ureteroscopy to take out the detached part of the stent eventually.A section of the device did not remain inside the patient¿s body.
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications, visional inspection and quality control of the returned device was conducted during the investigation.The device is shipped with an instruction for use (ifu) that describes the intended use, and specific items are addressed such as: the visual inspection of the returned device reported the stent returned in three segments, separated in two locations.Point of first separation @ 12cm from the coil, second point of separation occurred @15.8cm from the coil, length of this segment measured 3.8cm.Third segment measured 10cm from point of second separation to the coil.Points of separation had mating fractures total length of stent measured 28cm between coils indicating no missing pieces.The complaint device was returned therefore, an investigation evaluation was performed.There is no evidence to suggest the product was not made to specification.Review of device history record shows no nonconforming events which could contribute to this failure mode.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.The instructions for use indicate that an acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.However, it is possible that the user technique contributed to this event.A definitive root cause cannot be established or reported at this time.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
It was reported that a (b)(6) male patient had a stent placed in (b)(6) 2015.After several months, the stent was found to be surrounded by calculus.Thus, the stent was removed in late (b)(6) 2016.The patient had cystolith when reviewing after the procedure.The surgeon operated using the pneumatic lithotripsy under ureteroscope.The stent detached while removing.The user took an ureteroscopy to take out the detached part of the stent eventually.A section of the device did not remain inside the patient¿s body.

• 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: 6003410
• Report Number: 1820334-2016-01090
• Device Sequence Number: 18855236
• Product Code: FAD
• UDI-Device Identifier: 00827002151475
• UDI-Public: (01)00827002151475(17)180622(10)5975644
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 133628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2016
• Supplement Report FDA Received Date: 01/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PNEUMATIC LITHOTRIPSY PROBE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR