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

Model Number	G23406
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/28/2017
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
It was reported that during a percutaneous nephrolithotomy (pcnl) procedure, while attempting to adjust the stent the tether broke on the universa firm ureteral stent inside the patients body.They were able to retrieve the tether.Due to the breakage of the tether they were unable to adjust the pigtail and had to turn the patient on their back and adjust the pigtail through the urethra, which resulted in longer operating time.There were no additional adverse effects to the patient.Requested additional information regarding the additional time it took them to complete the procedure.The customer indicated the device was not available for return.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the universa firm ureteral stent was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.A review of complaint history, the device history record, specifications and quality control data was conducted.A review of the device history record found no non-conformances were noted.A review of complaint history for this product/lot number combination revealed this is one of two complaints associated with the complaint device lot number 8153638.The second complaint is for the failure mode; tether stretching.The second complaint is related to this same occurrence.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.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Based on the information available, a definitive root cause cannot 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 FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7147392
• Report Number: 1820334-2017-04585
• Device Sequence Number: 1238186
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)200818(10)8153638
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2018

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: G23406
• Device Catalogue Number: UFH-626-RT1
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/15/2018
• 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