MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number 3820

Device Problem Entrapment of Device (1212)

Patient Problems Cardiopulmonary Arrest (1765); No Code Available (3191)

Event Date 08/08/2018

Event Type  Injury  

Event Description

It was reported that a balloon lodged in patient's artery and patient complications occurred.A 06/3.00 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon became lodged in the patient's left main artery.The patient had very heavy calcium in the left anterior descending artery (lad) to left main (lm).These vessels were not stented; however, the circumflex was stented to the bifurcation.The patient was coded on the table and an impella was placed to help stabilize the patient.The patient was rushed to open heart surgery and does not have a good chance of surviving.

• Brand Name: FLEXTOME CUTTING BALLOON
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7842621
• MDR Text Key: 119073697
• Report Number: 2134265-2018-60593
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729808268
• UDI-Public: 08714729808268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: 3820
• Device Catalogue Number: 3820
• Device Lot Number: 0020038214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2018
• Initial Date FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 69 YR