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

Model Number	TG0709009
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	01/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch report is for administration purposes only.The device was used in treatment and not returned for analysis as device discarded by the user facility.There was no device performance related failure reported by the user.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.Risk assessment is not required as no device malfunction reported.No further investigation is required.Based on the investigation, a capa is not required as there was no issue reported for the device performance or quality.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 that 2 days post the index procedure, on the (b)(6) 2021 patient had thrombosed leg and intervention performed to treat thrombosed legs.Patient died from multi organ failure after reintervention.As per physician patient death is related to the procedure and not device.Tourguide steerable guiding sheath work as intended and no product malfunction reported.No additional information is available.
Additional Manufacturer Narrative
This medwatch report is for administration purposes only.The device was used in treatment and not returned for analysis as device discarded by the user facility.There was no device performance related failure reported by the user.The device history record was reviewed to confirm that the device passed all applicable in-process and final inspections.No further investigation is required.Based on the investigation, a capa is not required as there was no issue reported for the device performance or quality.The event will be re-evaluated if additional information becomes available.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: TOURGUIDE STEERABLE SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd; palm harbor FL 34683
• MDR Report Key: 11417523
• Report Number: 1035166-2021-00029
• Device Sequence Number: 3522530
• Product Code: DYB
• UDI-Device Identifier: 00643169936249
• UDI-Public: 00643169936249
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2021

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 Expiration Date: 07/01/2023
• Device Model Number: TG0709009
• Device Catalogue Number: TG0709009
• Device Lot Number: C8-20226
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR