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

Model Number T1106

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

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

Event Date 09/24/2019

Event Type  malfunction  

Event Description

(b)(6) hospital contacted biotrace medical and communicated that they had experienced a case where they had an issue with stabilizer retraction: "i have a tempo wire that the stabilizers did not retract when the md was removing the wire." there was no patient injury associated with the complaint.

• Brand Name: TEMPO TEMPORARY PACING LEAD
• Type of Device: TEMPORARY PACING LEAD
• Manufacturer (Section D): BIOTRACE MEDICAL, INC.; 3925 bohannon dr. #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, CA 94025 ; 6507794999
• MDR Report Key: 9243283
• MDR Text Key: 208598254
• Report Number: 3013472601-2019-00004
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2020
• Device Model Number: T1106
• Device Catalogue Number: T1106
• Device Lot Number: 31158
• 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: 09/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• 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: 74 YR
• Patient Weight: 90