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

Catalog Number UFH-824-RT1

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Pma/510k #: k161236.A follow up report will be submitted should additional relevant information become available.

Event Description

It has been reported, during an unspecified procedure using a universa firm ureteral stent set, "the withdraw thread (tether) on the proximal tip of the stent broke while placing the stent.[the physician] was able to engage (grasp) the stent with a 8 fr dilator and salvage (remove), [the complaint device]." a new stent was placed to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Reviews of manufacturing instructions and quality control data were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.There have been no changes in design, manufacturing or materials that likely contributed to this complaint.There is no evidence to suggest the product was not made to specifications.A review of the device history record could not be completed due to lack of lot information from the user facility.The same customer has reported similar events, and in those cases, the tethers returned confirmed the customers complaints that the tethers were separated (mfg.Reference report #s: 1820334-2019-01825 and 1820334-2019-02005).Controls were found to be in place for the tensile strength of the tether.It is possible that the material properties, as specified for the tether, do not meet the preference of the customer.Cook inc offers more than one tether option for this product line and the alternative braided tether may better meet the customers preferences.The cause for the observed separated tether could not be established.Per the quality engineering risk assessment, no further action is warranted.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8836444
• MDR Text Key: 156911299
• Report Number: 1820334-2019-01826
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UFH-824-RT1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1