MAUDE Adverse Event Report: TELEFLEX MEDICAL OEM UROPASS AS 10/12FR X 46 CM 5/BX

Model Number	61046BX
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigations.
Event or Problem Description
It was reported that during an unspecified procedure the device access sheath tip broke off in patient.The broken tip was retrieved successfully with no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the customer response/updates and legal manufacturer's investigation.The subject device was not returned for evaluation.The subject device was disposed by the user facility.A dhr (device history record) review was conducted and both dilator lots used for the manufacture of the device lot passed inspection and no abnormalities were noted.An investigation was completed by the oem (original equipment manufacturer) and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be environmental exposure of the device, which resulted in degradation and embrittlement of the polymer.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
Updates on the event reported: further communication with the customer conveyed the following information: customer stated that the subject device is not returning for evaluation.The subject device was disposed.The intended procedure was completed (did not provide the type/specific procedure).Customer stated no patient harm, no user injury.No further details provided.

• Brand Name: UROPASS AS 10/12FR X 46 CM 5/BX
• Common Device Name: UROPASS
• Manufacturer (Section D): TELEFLEX MEDICAL OEM; 3750 annapolis lane n, ste 160; plymouth MN 55447
• MDR Report Key: 12268615
• Report Number: 3003790304-2021-00131
• Device Sequence Number: 4376752
• Product Code: KNY
• UDI-Device Identifier: 00821925035331
• UDI-Public: 00821925035331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: 61046BX
• Device Lot Number: 09F1700101
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 09/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1