MAUDE Adverse Event Report: OSCOR INC. DIREX STEERABLE SHEATH; INTRODUCER, CATHETER

Model Number	M004DS100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used in treatment.The device was not returned for analysis, therefore, the exact cause of the device issue cannot be determined and the clinical observation could not be confirmed.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.The following controls are in place to mitigate the reported device issue.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 during right aflutter ablation procedure there was back bleeding through hemostasis valve of direx sheath.The issue was observed immediately and was adequately managed.Using the same sheath, the procedure was successfully ablated and terminated the arrhythmia.The sheath was disposed of and not available for return.No adverse patient effects reported.

• Brand Name: DIREX STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• MDR Report Key: 11588135
• Report Number: 1035166-2021-00036
• Device Sequence Number: 2955488
• Product Code: DYB
• UDI-Device Identifier: 08714729858904
• UDI-Public: 08714729858904
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K120459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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 Expiration Date: 02/01/2023
• Device Model Number: M004DS100
• Device Catalogue Number: M004DS100
• Device Lot Number: C8-19068
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1