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

Model Number	G15146
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510k #: k172017.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, prior to an unknown procedure using a filiform double pigtail ureteral stent set, the product was found to be broken.The tip of the pigtail seemed to be split.There were no photos available and the hospital discarded the device.The procedure was completed by using another new device.No adverse effects were reported due to the alleged malfunction.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: e1.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformities related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformities, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control and no related gaps in production or processing controls were noted.The complainant did not return the complaint device to cook for investigation.Cook has not received a similar complaint device for evaluation for a similar failure mode in the past.No photos were provided.A search of the nadc database shows all devices from the complaint lot have been shipped.Therefore, o similar product from the same lot is available for investigation.Based on the provided information the cause of the event cannot be determined.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database 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
No additional information has been 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: 9557239
• Report Number: 1820334-2020-00067
• Device Sequence Number: 19394502
• Product Code: FAD
• UDI-Device Identifier: 00827002151468
• UDI-Public: (01)00827002151468(17)220327(10)9624055
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 03/27/2022
• Device Model Number: G15146
• Device Catalogue Number: 133626
• Device Lot Number: 9624055
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/24/2019
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/07/2020
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1