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U.S. Department of Health and Human Services

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

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BIOTRACE MEDICAL, INC. TEMPO TEMPORARY PACING LEAD Back to Search Results
Model Number TC1106
Device Problem Material Fragmentation
Event Date 12/18/2019
Event Type  Injury  
Event 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.

 
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Brand NameTEMPO TEMPORARY PACING LEAD
Type of DeviceTEMPO 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 CA 94025
Manufacturer Contact
ken xavier
3925 bohannon dr.
suite #200
menlo park , CA 94025
MDR Report Key9603633
Report Number3013472601-2020-00001
Device Sequence Number1
Product CodeLDF
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/10/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/17/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/13/2020
Device MODEL NumberTC1106
Device Catalogue NumberTC1106
Device LOT Number31035
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/23/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/13/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/17/2020 Patient Sequence Number: 1
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