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U.S. Department of Health and Human Services

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

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BIOTRACE MEDICAL, INC. TEMPO TEMPORARY PACING LEAD TEMPORARY PACEMAKER WIRE Back to Search Results
Lot Number 31140
Device Problems Material Fragmentation; Device Operates Differently Than Expected
Event Date 10/01/2019
Event Type  Injury  
Event Description

Pt underwent tavr for severe aortic stenosis on (b)(6) 2019. During the procedure, a 6-fr tempo temporary pacing wire was inserted and advanced into the right ventricle under fluoroscopy. The rv tynes were deployed successfully. The wire was connected to a pacing box with a backup rate of 40 bpm. During wire removal on (b)(6) 2019, 1-2mm piece of the soft plastic tip of the catheter broke off and is believed to be retained, likely in a small pulmonary vein and cannot be removed.

 
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Brand NameTEMPO TEMPORARY PACING LEAD
Type of DeviceTEMPORARY PACEMAKER WIRE
Manufacturer (Section D)
BIOTRACE MEDICAL, INC.
menlo park CA
MDR Report Key9225453
Report Number9225453
Device Sequence Number1
Product CodeLDF
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 10/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT Number31140
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/14/2019
Distributor Facility Aware Date10/01/2019
Event Location Hospital
Date Report TO Manufacturer10/14/2019
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 10/23/2019 Patient Sequence Number: 1
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