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

Model Number	TC1106
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	12/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During the procedure the patient experienced a pericardial effusion.Dr.(b)(6) who placed the tempo lead stated that he believed that the perforation occurred during the initial placement of the tempo lead.This is supported by his statement that the tempo lead was placed "way out" to the apex of the right ventricle and in spite of this typically optimal position, pace capture could not be attained.Dr.(b)(6) repositioned the tempo lead twice and was ultimately able to obtain a capture threshold below 1ma (generally considered optimal).Subsequent to placement of the lead the patient was noted to be hypotensive, which was ultimately determined to be related to a pericardial effusion.Surgery was performed on the patient to close a small perforation in the apex of the heart.Dr (b)(6) stated that he used the introducer aid to advance the tempo lead into the introducer sheath and that he did not have any difficulty during tempo lead insertion or placement.He stated that the soft tip looked normal at the time of the final position in the apex of the right ventricle and was not kinked or "offset".He also stated that the patient was (b)(6) and at risk of an apical perforation by virtue of his age and morbidities.While the soft tip of the tempo lead appeared to be damaged, it is not known if the device malfunctioned or if there was misuse of the device.

• Brand Name: TEMPO TEMPORARY PACING LEAD
• Common Device Name: TEMPO TEMPORARY PACING LEAD
• Manufacturer (Section D): BIOTRACE MEDICAL, INC.; 3925 bohannon dr.; suite #200; menlo park CA 94025
• MDR Report Key: 9603633
• Report Number: 3013472601-2020-00001
• Device Sequence Number: 16769410
• Product Code: LDF
• UDI-Device Identifier: 10866899000210
• UDI-Public: 10866899000210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 01/10/2020

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 Expiration Date: 06/13/2020
• Device Model Number: TC1106
• Device Catalogue Number: TC1106
• Device Lot Number: 31035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/17/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Weight: 88