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

Lot Number 31140

Device Problems Material Fragmentation (1261); Device Operates Differently Than Expected (2913)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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.

• Brand Name: TEMPO TEMPORARY PACING LEAD
• Type of Device: TEMPORARY PACEMAKER WIRE
• Manufacturer (Section D): BIOTRACE MEDICAL, INC. ; menlo park CA
• MDR Report Key: 9225453
• MDR Text Key: 163975974
• Report Number: 9225453
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 31140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2019
• Distributor Facility Aware Date: 10/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Weight: 59