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

Model Number	M004DS200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the end of the sheath was leaking during an ablation procedure, there were no patient complications reported.The procedure was completed successfully.
Additional Manufacturer Narrative
The device was in use for treatment.The device was not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.However, following controls are in place to mitigate the reported product issue.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): leak test: sample size: 100% perform leak test according to procedures based on available leak tester.The leak test is performed by manufacturing personnel and is observed by quality assurance personnel.Per instructions for use (ifu): the steerable sheath must be thoroughly flushed with either saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.Wet the dilator shaft with sterile saline solution prior to insertion through the hemostatic valve.Note: 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.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.
Additional Manufacturer Narrative
The device was in use for treatment.The device was not returned for analysis, therefore, the exact cause of the product issue cannot be determined and the clinical observation could not be confirmed.However, following controls are in place to mitigate the reported product issue.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): leak test: sample size: 100% perform leak test according to procedures based on available leak tester.The leak test is performed by manufacturing personnel and is observed by quality assurance personnel.Per instructions for use (ifu): the steerable sheath must be thoroughly flushed with either saline or heparinized saline and free of air prior to use to avoid air embolism to the patient.Wet the dilator shaft with sterile saline solution prior to insertion through the hemostatic valve.Note: 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.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
The customer reported that the end of the sheath was leaking during an ablation procedure, there were no patient complications reported.The procedure was completed successfully.

• Brand Name: DIREX¿ STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683 1816
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 13001280
• Report Number: 1035166-2021-00153
• Device Sequence Number: 17322258
• Product Code: DYB
• UDI-Device Identifier: 08714729858928
• UDI-Public: 08714729858928
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2021

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: 06/01/2024
• Device Model Number: M004DS200
• Device Catalogue Number: M004DS200
• Device Lot Number: C8-22015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown