MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 12/14FR X 38 CM 5/BX; URETERAL CATHETER

Model Number	61238BX
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	Malfunction
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
The device referenced in this report has not been returned to olympus for evaluation (although it is anticipated 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
Additional information: this medical device report (mdr) is related to patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A dhr review was performed by the original equipment manufacturer (oem).There was one nonconformity noted for tip outer diameter.The lot was then further reviewed and the lot passed with no other nonconformities.It has been over 4 years since the subject device was manufactured.Based on the results of the oem investigation, the root cause was found to be embrittlement and degradation of the dilator polymer due to variable storage methods and environment exposure in health care facilities.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
The customer returned all available stock, which was (b)(4) units with 6 different lot numbers.The device reported as broken in this complaint was not likely returned, as only unopened devices were returned.A research and development investigation was performed and came up with the following conclusions: uropass dilator tip breakage is proposed to be mainly caused by inconsistent manufacture process of polyethylene (pe) dilator, lot-by-lot.The unfavorable oxidation of polyethylene dilator material is proposed to be occurred during dilator manufacture thermal process cycle, in which the thermos-oxidation could cause brittle fracture of uropass dilator tip materials for special lots.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 have affecting on uropass products for every lots but not for special lots.Uropaas dilator tip buckling testing should be very helpful for supplier to check the quality of uropass dilator tip for each lot to make sure if it meets osta specifications or not.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

• Brand Name: UROPASS AS 12/14FR X 38 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.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15941611
• Report Number: 3011050570-2022-00127
• Device Sequence Number: 6059531
• Product Code: KNY
• UDI-Device Identifier: 00821925005983
• UDI-Public: 00821925035409
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: 61238BX
• Device Lot Number: 09B1900153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/28/2023; 06/12/2023
• Initial Report FDA Received Date: 12/08/2022
• Supplement Report FDA Received Date: 04/26/2023; 07/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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
• Patient Sex: Unknown