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

Model Number G23382

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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

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 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.

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
• 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: 6778152
• MDR Text Key: 82486856
• Report Number: 1820334-2017-02293
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002233826
• UDI-Public: (01)10827002233826(17)191019(10)7371706
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: G23382
• Device Catalogue Number: USH-724-RT1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 08/09/2017; 09/15/2017
• Supplement Dates FDA Received: 08/10/2017; 09/18/2017
• Date Device Manufactured: 10/19/2016
• 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