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

Model Number	D141103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Conclusion not yet available, evaluation in process.A follow-up report will be submitted as soon as the investigation is complete.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.
Event or Problem Description
It was not possible to open the balloon catheter fully (inflation index <0,7), changing the balloon was necessary.After changing the balloon patient had st elevations in the body surface ecg: apparently with the changing some air was introduced in the patient.There was a 20 minute delay in the procedure.After the procedure, when the patient was not more under anesthesia, he could not move his one hand/arm and had speech disorders.The neurologist ordered a ct scan of the head.Nothing was found.After a while the symptoms got better.The next day the patient received an mri of the head and small air embolisms were found.
Additional Manufacturer Narrative
The following sections were updated in follow-up 1.The device was not returned for analysis.The investigation was focused 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.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.Qa final inspection of the finished adaptor per procedure "bipolar lead adaptors/extensions final inspection".100% inspection of product has to be performed under 10x microscope.Set screws and transport protection pin inspection (visual inspection) screw seals (two knobs on the receptacle) are cut approximately in the center and are shaped as a trokar cut.They will open during the insertion of the screwdriver and will reseal after removing the screwdriver.Insert the appropriate "test" connector into the receptacle and tighten the set screw using the 14 in/oz.Torque wrench (either (b)(6)).The torque wrench must click which verifies the set screw was tightened correctly.Instructions for use (ifu) precautions, directions for use: 1.Do not remove the connector of the lead to be adapted.2.Insert a torque wrench through the screw seals of the bipolar is-1 receptacle and turn both screws 1/4 - 1/2 turn (no more than 1/2 turn) counterclockwise and remove the white safety transportation pin "a" 3.Insert the lead connector completely into the receptacle part of the extension.Confirm that the connector pin is visible in hole "b" of the receptacle.4.Tighten both screws "c" of the receptacle with the screwdriver.A ligature may be placed in the groove of the receptacle's end to prevent body fluids from ingressing.5.After removing the screwdriver, use silicone medical adhesive on the screw seals for protection against body fluid ingression.No corrections or corrective actions will be taken.Device d was not returned for analysis and review of the manufacturing documents did not reveal any discrepancies that would have contributed to this event.This complaint is non-verifiable.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: GUIDESTAR¿ STEERABLE GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 16084045
• Report Number: 1035166-2023-00001
• Device Sequence Number: 6382591
• Product Code: DYB
• UDI-Device Identifier: 00885672010911
• UDI-Public: 00885672010911
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140406
• 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,Followup
• Report Date (Section B): 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: D141103
• Device Catalogue Number: D141103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2022
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 01/02/2023
• Supplement Report FDA Received Date: 07/06/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Unknown