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

Model Number	G23405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: cook standard guide wire, sensor guide wire (boston scientific).(b)(6).(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It is reported a universa firm ureteral stent set was placed (b)(6) 2018.On (b)(6) 2019, the stent was removed.The stent was totally encrusted and very difficult to remove, extending operating time.The stent was being changed due to the patient's complex medical history.No additional consequences to the patient have been reported as occurring.Additional details regarding the patient and the event have been requested.At this time, no further information has been provided.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable additional information: d10.Investigation evaluation: reviews of complaint history, device history record, manufacturing instructions, quality control data and the instructions for use(ifu) 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.There is no evidence to suggest the product was not made to specifications.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "the universa® firm stents must not remain indwelling more than twelve (12) months.The universa® soft stents must not remain indwelling more than six (6) months.If the patient¿s status permits, the stent may be replaced with a new stent." "these stents are not intended as permanent indwelling devices." "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." "individual variations of interaction between stents and the urinary system are unpredictable." "periodic evaluation via cystoscopic, radiographic, or ultrasonic means is suggested.The stent must be replaced if encrustation hampers drainage." the device is supplied with instructions for use which includes cautions which refer to monitoring for stent encrustation and that individual variations of interaction between stents and the urinary system are unpredictable.A clinical assessment of the complaint was carried out which concluded, the most probable contributing factor is human anatomy related.The clinical specialist also stated the fact that stents are in the urinary tract already predisposes the device to urine¿s elements.Ureteral stent encrustation is a known inherent risk of the device.The rate and severity of encrustation is influenced by many factors.The cause of the complaint is attributable to encrustation a known inherent risk of the device.The complaint was confirmed based on the customers testimony.A review of production processes, quality inspection documentation and the device history records did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The risk analysis for this failure mode was reviewed, and it was determined that no additional risk mitigating activity is required.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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 or Problem Description
There is no new patient or event information to report.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8609397
• Report Number: 1820334-2019-01050
• Device Sequence Number: 2339516
• Product Code: FAD
• UDI-Device Identifier: 10827002234052
• UDI-Public: (01)10827002234052(17)210821(10)9109280
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K961446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: G23405
• Device Catalogue Number: UFH-624-RT1
• Device Lot Number: 9109280
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 64 YR
• Patient Weight: 126