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

Catalog Number USH-624-RT1

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 second, 7 fr universa soft ureteral stent set was used and the same issue occurred.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.Additional patient and event details have been requested but not yet received at the time of this report filing.As reported, there were no adverse effects to the patient due to this occurrence.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: the universa soft ureteral stent set was not returned for evaluation and no photographs were provided.Without the complaint device, a physical investigation was not able to be completed.The investigation included a review of the 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 could not be performed as the lot number of the device was not provided.A review of complaint history for this product lot also could not be performed.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
• 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: 6783927
• MDR Text Key: 82600837
• Report Number: 1820334-2017-02294
• Device Sequence Number: 1
• Product Code: FAD
• 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
• Report Date: 12/12/2017

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 Catalogue Number: USH-624-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: 08/10/2017
• Supplement Dates Manufacturer Received: 12/08/2017
• Supplement Dates FDA Received: 12/12/2017
• 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