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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION FLEXTOME CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 3824
Device Problem Material Rupture (1546)
Patient Problems Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Shock (2072)
Event Date 11/25/2021
Event Type  Injury  
Event Description
It was reported that the patient experienced severe slow blood flow, hypotension, and shock.A 15/3.75 flextome cutting balloon was selected for use on the left main truncal lesion.During the procedure, it was noted that the balloon ruptured resulting in slow blood flow, hypotension, and shock.Treatment with balloon dilation and rapid stent implantation was required.Blood flow was restored by pressure boost.No further patient complications were reported.
 
Event Description
It was reported that the patient experienced severe slow blood flow, hypotension, and shock.A 15/3.75 flextome cutting balloon was selected for use on the left main truncal lesion.During the procedure, it was noted that the balloon ruptured resulting in slow blood flow, hypotension, and shock.Treatment with balloon dilation and rapid stent implantation was required.Blood flow was restored by pressure boost.No further patient complications were reported.It was further reported that the target lesion had 95% stenosis.The balloon ruptured upon second inflation at 8 atmospheres for 5-8 seconds.The device was pulled back and completely removed from the patient's body and the procedure was completed with a non-boston scientific high-pressure balloon.After rapid vascular treatment and drug use, the patient's condition improved.No further patient complications were reported.
 
Event Description
It was reported that the patient experienced severe slow blood flow, hypotension, and shock.A 15/3.75 flextome cutting balloon was selected for use on the left main truncal lesion.During the procedure, it was noted that the balloon ruptured resulting in slow blood flow, hypotension, and shock.Treatment with balloon dilation and rapid stent implantation was required.Blood flow was restored by pressure boost.No further patient complications were reported.It was further reported that the target lesion had 95% stenosis.The balloon ruptured upon second inflation at 8 atmospheres for 5-8 seconds.The device was pulled back and completely removed from the patient's body and the procedure was completed with a non-boston scientific high pressure balloon.After rapid vascular treatment and drug use, the patient's condition improved.No further patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the complaint device was received for product analysis.A visual and microscopic examination of the balloon found the wings to be in a deflated state and had been subjected to positive pressure.The returned device was attached to an encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.Liquid was observed to be leaking from a dual spray balloon pinhole located in the midsection of the balloon material.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.A visual and tactile examination identified multiple hypotube kinks.No other issues were identified during the product analysis.
 
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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
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13177428
MDR Text Key283319494
Report Number2134265-2021-16472
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/25/2023
Device Model Number3824
Device Catalogue Number3824
Device Lot Number0025266766
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age58 YR
Patient SexMale
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