MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 11/13FR X 54 CM 5/BX; URETERAL CATHETER

Model Number	61154BX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation (although it is expected to be).The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reports during a cysto-ureteroscopy procedure using a uropass ureteral access sheath dilator, the sheath tip broke off inside the patient¿s bladder when the physician was attempting to advance it over the wire into the ureter.The device fragments were retrieved.The patient did not experience any adverse effects as a result of this occurrence.The patient's current condition is reported as "stable." there were no procedural or anatomical challenges that could have contributed to the device breaking.The customer examined a like device still sealed in the package.After trying to wiggle the device inside the package, the device snapped inside the package.Additional comment by physician "additional devices were checked while in the packaging/unopened and showed same defect." one image was provided showing a device broken in the package.Clarifying information has been requested, at this time, no additional information has been provided.The customer stores the devices in sterile core hanging up the way they are designed.Case with patient identifier (b)(6) reports the patient event case with patient identifier (b)(6) reports the device broken in the package.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The subject device for this complaint was not returned to olympus for a physical evaluation.However, photos of the subject device were reviewed, and the device was confirmed to be broken.Furthermore, the customer returned all remaining uropass devices in their inventory to olympus.One of the returned lots from the inventory shares the same lot number as the subject device in this complaint.These returned devices underwent further investigation by olympus.A review of the device history record found only one nonconformance and that was for over dilator length and not a tip related failure.No other issues were found that could have related to the failure in the tip.It has been over 4 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the reported event is as follows: 1.Uropass dilator tip breakage is proposed to be mainly caused by the inconsistent manufacturer¿s process of the polyethylene (pe) dilator, lot-by-lot.2.The unfavorable oxidation of polyethylene dilator material is proposed to occur during manufacturer thermal process cycle of the dilator, in which thermos-oxidation could cause brittle fracture of uropass dilator tip materials for special lots.3.Generally speaking, photooxidation of polyethylene or uropass dilator material could occur during the whole products cycle including sterilization, and shelf life.In other words, it will influence uropass products for every lot but not for special lots.4.Uropass dilator tip buckling testing should be very helpful for suppliers to check the quality of uropass dilator tip for each lot to make sure if it meets osta specifications or not.Since the actual device captured in this complaint was not returned to olympus for a physical evaluation, d9 has been corrected to "no." however, since a photo of the device was reviewed and the reported defect was confirmed, h3 has been updated to "yes." finally, new information has been added to h4.Olympus will continue to monitor field performance for this device.

• Brand Name: UROPASS AS 11/13FR X 54 CM 5/BX
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15941597
• Report Number: 3003790304-2022-00326
• Device Sequence Number: 12314699
• Product Code: KNY
• UDI-Device Identifier: 00821925035386
• UDI-Public: 00821925035386
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K051593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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
• Operator of Device: Health Professional
• Device Model Number: 61154BX
• Device Lot Number: 09J1800111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Unknown
• Patient Weight: 104 KG