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

Model Number G23406

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Occupation: other non-healthcare professional: risk manager.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported in medwatch report mw5094047, during a left ureteroscopy and the removal of a universa firm ureteral stent, the stent ripped and a portion was left inside of the patient.Upon attempting to remove the previous left ureteral stent, the stent ripped and only a small portion if the stent was able to be removed.The retained portion was encrusted.A laser lithrotripsy was attempted.A new left ureteral stent was placed distally to the previous retained portion of the left ureteral stent.There are no current details about how the retained device segment will be retrieved.Additional details have been requested.A follow up report will be submitted when additional information becomes available.

Manufacturer Narrative

Investigation - evaluation: it was reported in medwatch report, during a left ureteroscopy and the removal of a universa firm ureteral stent in a 58-year-old male weighing 68.5 kg, the stent ripped, and a portion of the stent was left inside of the patient.Upon attempting to remove the previous left ureteral stent, the stent ripped and only a small portion of the stent was able to be removed.The retained portion was encrusted.The stent was originally placed (b)(6) 2020 and attempted removal occurred (b)(6) 2020.A laser lithotripsy was attempted.A new left ureteral stent was placed distally to the previous retained portion of the left ureteral stent.There are no current details about how the retained device segment will be retrieved.No information was provided about how and how often the stent was monitored while insitu.No additional consequences to the patient have been reported as a result of this occurrence.Four attempts to obtain additional details have been made, with few relevant details provided.A document-based investigation was performed including a review of complaint history, device history record, instructions for use (ifu), and quality control data.The complaint device was not returned; therefore, no physical examinations could be performed.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.A review of the complaint history could not be completed due to lack of information from the user facility.The instructions for use (ifu) provides the following information to the user related to the reported failure mode: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.Individual variations of interaction between stents and the urinary system are unpredictable.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.The stent is not intended as a permanent indwelling device which should not exceed twelve months.The ifu includes the following potential adverse events: encrustation the complaint device was not returned.The stent was reported to be encrusted.A review of manufacturing procedure found controls to be in place including a pull test for samples of the tubing used in the manufacture of the stent.A clinical review of the complaint was carried out, the most likely factors contributing to this event include patient anatomy/condition and user technique/procedural.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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.

Event Description

Additional information was received on 12may2020: a ureteral stent was placed on (b)(6) 2020 in a 58 year old male patient.The final removal procedure occurred on (b)(6) 2020.

• 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: 10017212
• MDR Text Key: 191682774
• Report Number: 1820334-2020-00893
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002234069
• UDI-Public: (01)10827002234069(17)220927(10)10047164
• Combination Product (y/n): N
• PMA/PMN Number: K161236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2022
• Device Model Number: G23406
• Device Catalogue Number: UFH-626-RT1
• Device Lot Number: 10047164
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 05/12/2020
• Supplement Dates FDA Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 68