MAUDE Adverse Event Report: COOK INC BANDER URETERAL DIVERSION STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problem Complete Blockage (1094)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.(b)(4).The event is currently under investigation.

Event Description

It was reported the ureteral stent product ¿clogs immediately.¿ the reporter stated ¿stent should be replaced latest after four months because clog immediately.¿ the patient required an additional procedure due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation ¿ evaluation: the bander ureteral diversion stent set was not returned for an evaluation; therefore, a physical investigation could not be performed.The complaint report that the stent clogged immediately was unable to be confirmed.Based on the information provided, a definitive root cause cannot be determined or established at this time.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.A review of the device history record indicated that there were no non-conformances for this lot number.Additionally, a review of complaint history revealed this complaint to be one of two complaints with this lot number 7021020.The other complaint was reported by the same customer referencing the same device with a defect of ¿too soft, slips off too easily.¿ based on the quality engineering risk assessment; no further action is required.Cook medical has notified the appropriate personnel and the will continue to monitor the complaints database for similar complaints.

• Brand Name: BANDER URETERAL DIVERSION 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: 6181701
• MDR Text Key: 62601414
• Report Number: 1820334-2016-01509
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002180703
• UDI-Public: (01)00827002180703(17)190603(10)7021020
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 025227-OE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2017
• Date Device Manufactured: 06/03/2016
• 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