MAUDE Adverse Event Report: COOK INC UNIVERSA SOFT URETERAL STENT SET; FAD STENT, URETERAL

Model Number	G23383
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
A voluntary medwatch report was received.According to the report, a cook medical urologic stent was placed.After the stent with a tether was placed, the thin tether broke, which then required the stent to be removed, the stent to be re-threaded, and then replaced.There was no harm to the patient.The patient required additional anesthesia time for the removal, re-stringing of the tether and replacement of the stent.
Additional Manufacturer Narrative
Corrected information: initial report sent to fda changed to unknown.Cook medical received a voluntary medwatch report on form 3500 on oct 17, 2017 from the user facility.This form was attached to the previously sent medwatch report.It is not known if the user facility reported this event to the fda.Investigation ¿ evaluation: the universal soft ureteral stent set was not returned for an evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A documentation investigation was performed which included a review of complaint history, the device history record, instructions for use, quality control data, and specifications.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.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 found no non-conformances noted during manufacturing.A review of complaint history for this product lot revealed there have been no other complaints reported on the complaint device lot number 8099894.Based on the provided information a definitive root cause could not be determined.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: UNIVERSA SOFT URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6965222
• Report Number: 1820334-2017-03610
• Device Sequence Number: 1364925
• Product Code: FAD
• UDI-Device Identifier: 10827002233833
• UDI-Public: (01)10827002233833(17)200727(10)8099594
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2017

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: G23383
• Device Catalogue Number: USH-726-RT1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/09/2017
• Supplement Date Received by Manufacturer: 12/08/2017
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 12/13/2017
• 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: Required Intervention
• Patient Age: 72 YR