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

Model Number 3824

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 02march2022.It was reported that the device encountered difficulty crossing the lesion.A flextome cutting balloon was selected from treating the severely diseased left circumflex (lcx) artery from proximal to mid segment of the lesion.The lesion had a dense fibrotic tissue and mild calcium with almost 80% stenosis in mid segment with an unfavorable takeoff at the ostium.A non-bsc guidewire was used to cross the lesion.Pre-dilation was performed with a nc balloon.The 3.0x5mm flextome cutting balloon was navigated to the lesion site.The flextome cutting balloon did not cross due to the tortuosity in the lcx.Another balloon of smaller size was selected and crossed the lesion.The procedure was completed by deploying stent followed by post-dilatation.No patient complications were reported.However, device analysis revealed shaft seperation.

Manufacturer Narrative

Device evaluated by manufacturer: flextome cb monorail was returned for analysis.The device was received in three sections as a result of a complete breaks of the hypo tube and the shaft polymer extrusion.A visual and tactile examination identified a complete break in the hypo tube of the device.The break was located at approximately 2.2 cm distal of the strain relief.A visual and tactile examination identified a complete break in the shaft polymer extrusion of the device.The break was located at approximately 5.7 cm proximal to the proximal balloon cone.A visual examination identified that the balloon was in a deflated state and had been subjected to positive pressure.An examination of the balloon identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination identified no damage to the tip, marker bands or blades of the device.All blades were present and fully bonded to the balloon material.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13892200
• MDR Text Key: 287850639
• Report Number: 2134265-2022-03381
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2023
• Device Model Number: 3824
• Device Catalogue Number: 3824
• Device Lot Number: 0025327086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• 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 Age: 58 YR
• Patient Sex: Male
• Patient Weight: 69 KG