MAUDE Adverse Event Report: GYRUS ACMI, INC. UROPASS AS 10/12FR X 24 CM 5/BX; URETERAL CATHETER

Model Number	61024BX
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the reported issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that the tip of the outer sheath of the device was torn at the start of the procedure (an unspecified procedure).The device was not used on patient.The device was replaced and the intended procedure was completed using a similar device.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This is a supplemental report to correct the initial mdr.The initial medwatch reported that the tip of the outer sheath of the device was torn; however; device evaluation found the sheath was broken at the joint between the sheath and the funnel.Per the legal manufacturer, this issue of the sheath and funnel broken at the joint is not likely to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: UROPASS AS 10/12FR X 24 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: 16892249
• Report Number: 3003790304-2023-00183
• Device Sequence Number: 6163133
• Product Code: KNY
• UDI-Device Identifier: 00821925035317
• UDI-Public: 00821925035317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

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: 61024BX
• Device Lot Number: 09M2100148
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 11/07/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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