MAUDE Adverse Event Report: ABBOTT TREK

Model Number 1012275-12

Device Problems Material Fragmentation (1261); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Event Description

During coronary stenting on the left main, the physician inserted the abbott balloon and luge wire simultaneously.They were unable to cross the lesion and both were removed.The balloon was noted to have been fragmented.The equipment was never retained in the patient.The case proceeded without further incident.No patient harm.

• Brand Name: TREK
• Type of Device: TREK
• Manufacturer (Section D): ABBOTT; lel coyol alajuela, cr
• MDR Report Key: 5554234
• MDR Text Key: 42435391
• Report Number: MW5061538
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 1012275-12
• Device Catalogue Number: 1012275-12
• Device Lot Number: 41125G1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 61