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

Model Number G49866

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

(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

It is reported prior to an unspecified procedure using a universa firm ureteral stent set, the physician opened the package and found cracking at the pigtail end of the device.The procedure was completed with a second device of the same type.The distributor indicated the tether was not attached to the device upon its return.There were no adverse effects to the patient reported as a result of this occurrence.

Manufacturer Narrative

Event summary: it is reported prior to an unspecified procedure using a universa firm ureteral stent set, the physician opened the package and found cracking at the pigtail end of the device.The procedure was completed with a second device of the same type.The distributor indicated the tether was not attached to the device upon its return.There were no adverse effects to the patient reported as a result of this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, specifications, and quality control procedures and a visual inspection of the device were conducted during the investigation.One opened package containing a universa firm stent was returned for investigation.Visual examination confirmed the stent and positioner were received.The tether had been removed from the stent and was not returned.The proximal coil was torn starting at the first sideport continuing through the end of the coil.Additional damage was noted on the distal coil; the coil was slightly smashed on the first 4mm of the tapered end.The stent wired through both coils using a hsf-035-50qc wire guide; the wire transitioned through the coil.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.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 manufacturing instructions, specifications, or quality control 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 caution, "tether should be removed if stent is to remain indwelling longer than 14 days.Do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ based on the information available, investigation has concluded that the stent appeared to have been torn by the tether, though the circumstances that contributed to this could not be established.The slightly smashed tapered end of the device likely occurred due to a manufacturing deficiency that has been further investigated in a now closed capa, through which manufacturing improvements were implemented, after the manufacture of this product lot, to mitigate this failure mode.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 FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10257045
• MDR Text Key: 198323841
• Report Number: 1820334-2020-01285
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00827002498662
• UDI-Public: (01)00827002498662(17)221028(10)10111019
• Combination Product (y/n): N
• PMA/PMN Number: K161236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 09/04/2020

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 Expiration Date: 10/28/2022
• Device Model Number: G49866
• Device Catalogue Number: UFH-526
• Device Lot Number: 10111019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 07/10/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1