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

Model Number T1106

Device Problem Material Fragmentation (1261)

Patient Problem Pericardial Effusion (3271)

Event Date 08/11/2019

Event Type  Injury  

Event Description

Upon removal of the lead from the patient, a pericardial effusion was noted on echocardiogram.The effusion did not require intervention.It was observed that the soft tip of the lead was detached at the midpoint of the tip.

• 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 (Section G): BIOTRACE MEDICAL, INC.; 3925 bohannon dr. suite #200; menlo park,
• Manufacturer Contact: ken xavier ; 3925 bohannon dr. suite #200; menlo park, CA 94025 ; 6507794999
• MDR Report Key: 9038803
• MDR Text Key: 160615330
• Report Number: 3013472601-2019-00001
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10866899000203
• UDI-Public: (01)10866899000203
• 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: company representative,health
• 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: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T1106
• Device Catalogue Number: T1106
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2019
• 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): Other
• Patient Age: 62 YR