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	Nerve Damage (1979)
Date of Event	03/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was used in treatment and not returned for analysis.There was no device performance related failure reported by the user.This event is related to patient condition.No further investigation is required.The lot number was not provided by the customer, therefore the device history records could not be reviewed, however, inspection procedures require any oscor product pass all in-process and qa final inspection before shipping.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
Devices used during the case: - carto3 system sn: (b)(6) / v7.2.40.250 - ngen generator sn: (b)(6) - ngen pump sn: (b)(6).The caller confirmed that no other biosense webster devices have been used.Catheter used during the case: - helios star balloon - guides star - lasso star please note that all catheters have been discarded so the caller couldn't provide any lot numbers.The bwi representative confirmed that they didn't have any issue on the system, but it was reported that the patient had a phrenic nerve palsy during the ablation of the right pulmonary vein.The patient is alive.Procedure has been completed.No delay.Type of procedure: pulmonary vein isolation (pvi).No further action needed; the caller just wanted to report the adverse event.

• Brand Name: GUIDESTAR¿ STEERABLE GUIDING 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: daniel naut ; 3816 desoto blvd.; palm harbor, FL 34683-1816 ; 7279372511
• MDR Report Key: 17434512
• Report Number: 1035166-2023-00072
• Device Sequence Number: 18364080
• 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
• Report Date (Section B): 08/01/2023

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: 07/06/2023
• Initial Report FDA Received Date: 08/01/2023
• 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: Life Threatening
• Patient Sex: Unknown