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

Model Number	G23382
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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
The physician reported during stent placement using a 6 fr universa soft ureteral stent set, when placing the stent with the aid of the monofilament string, the string kept stretching and finally the string broke.A 7 fr universa soft ureteral stent set was then used and the same issue occurred; the monofilament string stretched and finally broke.As reported, no additional procedures were required as a result of these issues.No section of the device was left inside the patient's body.There were no adverse effects to the patient due to these issues.Additional patient and event detail has been requested but not been received at the time of this report.As reported, there were no adverse effects to the patient due to this occurrence.
Event or Problem Description
This event has been reported in two related manufacturer reports to reflect there were two device malfunctions reported to occur during the same procedure.The first report mfr.Report # 1820334-2017-02293 captures the first reported device issue.The second device issue has been captured in mfr.Report # 1820334-2017-02294.
Additional Manufacturer Narrative
Investigation ¿ evaluation: as anticipated, the universa soft ureteral stent set was not returned for evaluation.No photos have been provided.Without the complaint device, a physical investigation was not able to be completed.Based on the available information a definitive root cause could not be established at this time.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.The device history record was reviewed and no non-conformances were noted.A review of complaint history for this product/lot number combination revealed this complaint is the only reported complaint associated with this complaint lot number.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: 6778152
• Report Number: 1820334-2017-02293
• Device Sequence Number: 999032
• Product Code: FAD
• UDI-Device Identifier: 10827002233826
• UDI-Public: (01)10827002233826(17)191019(10)7371706
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2017

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: G23382
• Device Catalogue Number: USH-724-RT1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 08/09/2017; 09/15/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 08/10/2017; 09/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1