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

Model Number 3822

Device Problem Material Rupture (1546)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/14/2020

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred and the patient was sent for surgery.The calcified target lesion was located in the proximal and mid left circumflex artery.A 10/2.75 flextome cutting balloon was selected for use.During procedure, at first inflation, it was noted that balloon burst at 5 atm.The patient was sent for surgery.No further patient complications were reported.

Event Description

It was reported that a balloon rupture occurred and the patient was sent for surgery.The calcified target lesion was located in the proximal and mid left circumflex artery.A 10/2.75 flextome cutting balloon was selected for use.During procedure, at first inflation, it was noted that balloon burst at 5atm.The patient was sent for surgery.No further patient complications were reported.It was further reported that the proximal and mid left circumflex artery was moderately calcified.The device was completely removed from the patient without intervention.The patient was stable.

• 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
• MDR Report Key: 10123488
• MDR Text Key: 194144256
• Report Number: 2134265-2020-07215
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: 3822
• Device Catalogue Number: 3822
• Device Lot Number: 0024944049
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 60