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

Lot Number 31158

Device Problem Retraction Problem (1536)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2019

Event Type  malfunction  

Event Description

On (b)(6) 2019, a tempo wire was placed post tavr due to temporary left bundle branch block.Upon removal on (b)(6) 2019, the stabilizers would not retract despite multiple attempts.The wire and stabilizers were removed separately.Again, outside of the pt's body, they would not retract.

• Brand Name: BIOTRACE TEMPO TEMPORARY PACING LEAD
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): BIOTRACE MEDICAL, INC. ; menlo park CA
• MDR Report Key: 9234743
• MDR Text Key: 164074270
• Report Number: MW5090643
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/29/2020
• Device Lot Number: 31158
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 90