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

Model Number T1106

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2019

Event Type  malfunction  

Event Description

(b)(6) hospital reported that they experienced a case wherein the tip of the device had been damaged and a fragment was missing.Upon further discussion via phone, it was communicated that the tip could not be located within the patient under xray.Btmi advised that the tip is radiopaque.There was no patient injury associated with this complaint.

• Brand Name: TEMPO TEMPORARY PACING LEAD
• Type of Device: 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 drive; suite #200; menlo park 94025 ; 6507794999
• MDR Report Key: 9267971
• MDR Text Key: 217366435
• Report Number: 3013472601-2019-00005
• Device Sequence Number: 1
• Product Code: LDF
• UDI-Device Identifier: 10866899000203
• UDI-Public: 10866899000203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Model Number: T1106
• Device Catalogue Number: T1106
• Device Lot Number: 31140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 59