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

Model Number	G15145
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, during the procedure, when the doctor tried to reposition the catheter the rizo broke.Additional information provided on 03apr2019.No portion of the filiform double pigtail ureteral stent set that was broken had to be removed from the patient.The stent was removed because it had broken.No additional procedures were required and there were no adverse effects to the patient as a result of this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Investigation ¿ evaluation.The complaint device was not returned for an evaluation.Therefore, a device failure analysis could not be performed.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, manufacturing instructions, and quality control data.A review of the device history records for the set, stent component and the raw material found there were no non-conformances.A review of complaint history records revealed no additional complaints have been received on the complaint device lot.The device is supplied with the instructions for use (ifu) which includes the following precautions: do not force set components during placement, replacement or removal.Carefully remove the set components if any resistance is encountered.The stent must not remain indwelling more than twelve months.If the patient¿s status permits, the stent may be replaced with a new stent.A review of manufacturing procedures found that current controls for manufacturing and quality control are in place to assure functionality and device integrity prior to shipping.A cause for this complaint could not be established.Measures have been initiated to address this failure mode.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.

• 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: 8500704
• Report Number: 1820334-2019-00818
• Device Sequence Number: 16740197
• Product Code: FAD
• UDI-Device Identifier: 00827002151451
• UDI-Public: (01)00827002151451(17)220110(10)9437000
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

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: 01/10/2022
• Device Model Number: G15145
• Device Catalogue Number: 133624
• Device Lot Number: 9437000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1