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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Difficult to Remove (1528)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/01/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
It was reported by the user facility that a patient underwent a ureteral stent removal procedure.A (b)(6) male patient with a septic stone had a filiform double pigtail ureteral stent in place for approximately three months.The physician was removing the stent in order to remove the stone.The patient had been in icu for an extended time.When the attending physician tried to remove the stent, it would break off piece by piece.The complete removal of the stent took about one hour.The patient eventually expired and the physician believes if the removal of the stent had not taken so long the patient may have survived.There were no unintended sections of the device that remained inside of the patient¿s body.No further information was provided.
Additional Manufacturer Narrative
(b)(4).Reportable event type is death.The date of patient's death has not been provided.Multiple requests for additional information and the autopsy report have been made.These requests remain unanswered.
Additional Manufacturer Narrative
The filiform double pigtail ureteral stent was not expected or returned for an evaluation.Additionally, no photographs were provided.An autopsy report has been requested but has not been received.Without the actual device, an evaluation could not be performed and a definitive root cause of the stent separation cannot identified at this time.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 identified during the manufacturing process that would have caused or contributed to the reported product issue.A review of complaint history for this product/lot number combination revealed that this is the only complaint received.Measures have been initiated to address this failure mode.A review of the instructions for use (ifu) noted the following precaution: "improper handling can seriously weaken the stent.Acute bending or overstressing during placement may result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.Angulation of the wire guide or stent should be avoided.Use of a 0-degrees scope lens is recommended.Scope larger than 21.0 french are suggested.Individual variations of interaction between stents and the urinary system are unpredictable." cook medical will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6459889
• Report Number: 1820334-2017-00637
• Device Sequence Number: 13594124
• Product Code: FAD
• UDI-Device Identifier: 00827002151444
• UDI-Public: (01)00827002151444(17)190810(10)7185646
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 133622
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: 07/19/2017; 09/06/2017
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 08/03/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention