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

Model Number T1106/TC1106

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

Patient Problem Pericardial Effusion (3271)

Event Date 09/12/2019

Event Type  Injury  

Event Description

Patient was undergoing a permanent pacemaker implantation procedure and developed a pericardial effusion subsequent to removal of the tempo lead, which was kept in the patient for 3 days following a tavr procedure.Pericardiocentesis was required to drain the resulting tamponade.

• Brand Name: TEMPO TEMPORARY PACING LEAD
• Type of Device: TEMPORARY PACING LEAD
• Manufacturer (Section D): BIOTRACE MEDICAL INC.; 3925 bohannon dr.; suite #200; menlo park CA 94025
• Manufacturer Contact: ken xavier ; 3925 bohannon dr.; menlo park, CA 94025 ; 6507794999
• MDR Report Key: 9176363
• MDR Text Key: 162006792
• Report Number: 3013472601-2019-00003
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T1106/TC1106
• Device Catalogue Number: T1106/TC1106
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• 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: 93 YR