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

Catalog Number USH-600

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

Customer name and address- postal code: (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, during removal of a universa soft ureteral stent set placed two previously, the stent was noted to be encrusted and knotted.The physician was able, despite resistance, to successfully remove the device from the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary: as reported, during removal of a universa soft ureteral stent set placed two previously, the stent was noted to be encrusted and knotted.The physician was able, despite resistance, to successfully remove the device from the patient.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examinations were performed.The product lot is unknown.Thus, a device history record review could not be conducted.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which warn, ¿formation of knots in multi-length stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal,¿ and, ¿ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient`s condition and other patient specific factors.¿ based on the available information, cook has concluded that this event can be attributed to a known, inherent risk of the device as described in the ifu.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNIVERSA SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10501088
• MDR Text Key: 207329346
• Report Number: 1820334-2020-01644
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K151051
• 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: 09/25/2020

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-600
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 09/23/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1