MAUDE Adverse Event Report: XCARDIA INNOVATION XTRACTOR; LEAD EXTRACTION SHEATH

Catalog Number	MDS-01-5110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	05/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The report is submitted following a conversation with the physician for obtaining relevant background information.In the professional opinion of the physician, the event is not related to any device malfunction or misuse.There was no unusual behavior of the device, and the physician would have neither done anything differently nor use the device differently under the same circumstances.This procedure is a high-risk procedure, and such adverse events are well known risks of this procedure.For the conclusion, we believe there is a known inherent risk of the procedure.This report is submitted in an abundance of caution.
Event or Problem Description
During a lead extraction procedure, two leads were attempted to be removed from a 54-year old female patient indicated for lead extraction procedure due to icd malfunction.The procedure was performed under general anesthesia.Fluroscopy and trans-esophageal-echo were used throughout the extraction process.Leads were prepared with locking stylets.The first lead was removed successfully without complication using the xtractor device and a locking stylet.During the extraction of the second lead, approximately after passing the svc towards the atrium, a blood pressure drop was noted, suggesting that there was a tear in the svc or atrium, which was confirmed by echo.Accordingly, surgical intervention by sternotomy was required.

• Brand Name: XTRACTOR
• Common Device Name: LEAD EXTRACTION SHEATH
• Manufacturer (Section D): XCARDIA INNOVATION; rehovot ; IS
• Manufacturer Contact: gilat mor horesh ; 1 hamada st; rehovot ; IS
• MDR Report Key: 17439992
• Report Number: 3021719444-2023-00001
• Device Sequence Number: 14115327
• Product Code: DRE
• UDI-Device Identifier: 07290019371007
• UDI-Public: (01)07290019371007(10)MDS-027(17)230617(11)230117
• Combination Product (Y/N): N
• PMA/510(K) Number: K211679
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• 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 Expiration Date: 06/12/2023
• Device Catalogue Number: MDS-01-5110
• Device Lot Number: MDS-027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANTI COAGULATION MEDICATION; BRIDGE BALLOON; ELECTROCAUTERY; GENERAL ANESTHESIA, FLUIDS AND BLOOD MANAGEMENT; HISTORICALLY IMPLANTED ICD AND PACING LEADS; LEAD LOCKING STYLETS (LIBERATOR); TRANS-ESOPHAGIAL-ECHO; X-RAY FLUROSCOPY
• Outcome Attributed to Adverse Event: Disability; Hospitalization; Required Intervention; Life Threatening
• Patient Age: 54 YR
• Patient Sex: Female