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

Model Number 1012279-15

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2022

Event Type  malfunction  

Event Description

During lvc/ai procedure this coronary balloon came off the wire and was dislodged from the balloon wire and lodged on interventional wire.This balloon was not retained in the body.Fda safety report id# (b)(4).

• Brand Name: ABBOTT DILATATION CATHETER CORONARY BALLOON CATHETER
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA 95054
• MDR Report Key: 14188111
• MDR Text Key: 289985925
• Report Number: MW5109275
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 1012279-15
• Device Catalogue Number: 1012279-15
• Device Lot Number: 00713G1
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male