MAUDE Adverse Event Report: BIOTRACE MEDICAL INC. TEMPO; TEMPORARY PACING LEAD

Model Number T/TC1106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 02/26/2019

Event Type  Injury  

Event Description

The tempo, temporary intracardiac pacing lead, was placed in the right ventricle during a tavr (transcatheter aortic valve replacement) procedure.The patient experienced hemodynamic collapse prior to inserting the tavr valve.A pericardial effusion was detected on the intraoperative echo cardiogram after the hemodynamic collapse.The patient went to surgery and a perforation in the right ventricle was repaired and the aortic valve was successfully placed.There were no lasting injuries nor permanent impairment as a result of the event.Upon return to biotrace medical inc.A formal device investigation was conducted wherein there were no manufacturing, nor functionality issues detected.

• Brand Name: TEMPO
• Type of Device: TEMPORARY PACING LEAD
• Manufacturer (Section D): BIOTRACE MEDICAL INC.; 3925 bohannon drive suite #200; menlo park CA 94025
• Manufacturer (Section G): BIOTRACE MEDICAL, INC.; 3925 bohannon drive suite 200; menlo park CA 94025
• Manufacturer Contact: ken xavier ; 3925 bohannon drive suite 200; menlo park, CA 94025 ; 6507794900
• MDR Report Key: 8448537
• MDR Text Key: 139718207
• Report Number: 3013472601-2019-00002
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2019

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
• Device Operator: Other
• Device Expiration Date: 01/01/2020
• Device Model Number: T/TC1106
• Device Catalogue Number: T/TC1106
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 45