MAUDE Adverse Event Report: OSCOR INC. DIREX STEERABLE SHEATH; STEERABLE GUIDING SHEATH

Model Number	M004DS50S0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used for treatment.The device was not returned for analysis (device was lost), therefore, the clinical observation could not be confirmed.The investigation will focus on a review of product documentation.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.Per procedure destino steerable guiding sheath in-process and final inspection: perform leak test according to procedure based on available leak tester.The leak test is performed by manufacturing personnel and is observed by quality assurance personnel.This procedure is performed on 100% of the sheaths.The instructions for use (ifu) informs user: any device/component inserted through the hemostatic valve of the sheath should be wet and placed through the center of the valve to prevent tearing of the seal and leakage.Slowly remove the dilator from the sheath.Caution: rapid removal may damage the valve membrane resulting in blood flow through the valve.Based on the investigation, a capa is not required as findings did not identify a design, labeling or manufacturing non-conformity.In addition, there was no new failure mode identified and the risk remains acceptable.The event will be re-evaluated if additional information becomes available.Oscor will continue to monitor this event type and risk.
Event or Problem Description
It was reported the direx was removed from the package and when being flushed it leaked from the handle where the tubing attaches.It was used for treatment, however since they found the leak when flushing the direx, it was never put into the patient.A new direx was pulled and used with no issues.The patient was a male, approximately (b)(6), weight is unknown.The direx is not being returned for evaluation because it was lost.

• Brand Name: DIREX STEERABLE SHEATH
• Common Device Name: STEERABLE GUIDING SHEATH
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor, fl
• MDR Report Key: 10183952
• Report Number: 1035166-2020-00039
• Device Sequence Number: 3408546
• Product Code: DYB
• UDI-Device Identifier: 08714729858997
• UDI-Public: 08714729858997
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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 Expiration Date: 02/01/2023
• Device Model Number: M004DS50S0
• Device Catalogue Number: M004DS50S0
• Device Lot Number: C8-19180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR