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

Model Number G23406

Device Problem Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/28/2017

Event Type  Injury  

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 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.

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
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 7147392
• MDR Text Key: 95802679
• Report Number: 1820334-2017-04585
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)200818(10)8153638
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: G23406
• Device Catalogue Number: UFH-626-RT1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 02/23/2018
• Supplement Dates FDA Received: 03/15/2018
• Date Device Manufactured: 08/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention