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

Model Number	T1106
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/11/2019
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: TEMPORARY PACING LEAD
• Manufacturer (Section D): BIOTRACE MEDICAL, INC.; 3925 bohannon dr. suite #200; menlo park CA 94025
• MDR Report Key: 9038803
• Report Number: 3013472601-2019-00001
• Device Sequence Number: 2487462
• Product Code: LDF
• UDI-Device Identifier: 10866899000203
• UDI-Public: (01)10866899000203
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K160260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2019

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
• Operator of Device: Health Professional
• Device Model Number: T1106
• Device Catalogue Number: T1106
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR