MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT TREK BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number TREK 3.0 X 20MM

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/17/2020

Event Type  Injury  

Event Description

Shaft of abbott trek balloon broke off in patient's right leg during angioplasty procedure.Fda safety report id# (b)(4).

• Brand Name: ABBOTT TREK BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR
• MDR Report Key: 10627993
• MDR Text Key: 209996891
• Report Number: MW5097052
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TREK 3.0 X 20MM
• Device Catalogue Number: REF # 1012274-20
• Device Lot Number: 8031361
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 67