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

Model Number G49934

Device Problem Dent in Material (2526)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

The physician test the product before the ureterorenoscopy procedure, he found that there has a crease on side of drainage hole.It can't be used in procedure due to the crease, the physician opened a new set of stent to place into patient.There were no adverse effects reported due to this occurrence.

Event Description

There is no new patient or event information to report.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Additional information: results code: appropriate term/ code not available (4247): stent torn investigation ¿ evaluation visual inspection was performed.A document based investigation was also performed including a review of: specifications, manufacturing instructions, device history record, complaint history, and quality control data.The complainant returned one open package, part number ush-526 for investigation.The stent only was received, the tether was not returned.The return packaging confirms the lot number.Review of the device history record shows no nonconformance's related to this failure mode.There have been no other complaints reported for this lot number.Visual examination confirmed a tear in the material on the proximal coil.Closer examination revealed the tear originated at the last side port where the tether for stent is specified to be attached to the stent.The tether was not returned indicating that the stent may have been damaged in the process of removing the tether.No other damage found on the stent.Conclusion: the cause of the complaint was not established.The returned device confirmed the customers complaint, a 2mm long tear was identified, originating from the last side port on the stent.The side port where the tear was noted is also where the tether for stent is specified to be attached to the stent.The tether was not returned indicating that the stent may have been damaged in the process of removing the tether.Risk analysis was conducted and concluded no additional risk reduction was required.The appropriate internal personnel have been notified and we will continue to monitor 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 SOFT URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8609544
• MDR Text Key: 145113932
• Report Number: 1820334-2019-01125
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002499348
• UDI-Public: (01)00827002499348(17)210709(10)9003992
• Combination Product (y/n): N
• PMA/PMN Number: K151051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

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 Expiration Date: 07/09/2021
• Device Model Number: G49934
• Device Catalogue Number: USH-526
• Device Lot Number: 9003992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 06/10/2019
• Supplement Dates FDA Received: 07/05/2019
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Weight: 55