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

Model Number 3824

Device Problems Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2021

Event Type  Injury  

Event Description

It was reported that balloon burst occurred and the patient's vessel ruptured.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left main (lm) bifurcation lesion.A 15/3.75 flextome cutting balloon was selected for use.During the procedure, the balloon was advanced and slowly inflated.However, the image showed a contrast leakage.The device was removed with the guide catheter and pre-dilation balloon but was noted that it had burst.The physician rechecked by angiography and found that the patient's vessel was ruptured.The physician used a surrogate membrane stent to address the ruptured vessel and completed the procedure with a different device.No further patient complications were reported and patient was stable.

Manufacturer Narrative

Corrected b5 describe event or problem: the first report was submitted in error.Additional information received indicated that this report is a duplicate report.All event details have been submitted under tw# (b)(4).

Event Description

It was reported that balloon burst occurred and the patient's vessel ruptured.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left main (lm) bifurcation lesion.A 15/3.75 flextome cutting balloon was selected for use.During the procedure, the balloon was advanced and slowly inflated.However, the image showed a contrast leakage.The device was removed with the guide catheter and pre-dilation balloon but was noted that it had burst.The physician rechecked by angiography and found that the patient's vessel was ruptured.The physician used a surrogate membrane stent to address the ruptured vessel and completed the procedure with a different device.No further patient complications were reported and patient was stable.However, the first report was submitted in error.Additional information received indicated that this report is a duplicate report.All event details have been submitted under tw# (b)(4).

• 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: 13374584
• MDR Text Key: 286498048
• Report Number: 2134265-2022-00769
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/17/2022

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: 02/25/2023
• Device Model Number: 3824
• Device Catalogue Number: 3824
• Device Lot Number: 0025266766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 01/27/2022
• Supplement Dates Manufacturer Received: 01/29/2022
• Supplement Dates FDA Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2020
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 69 KG