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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 3822
Device Problem Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/29/2021
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.A microscopic examination of the balloon material identified a hole in the balloon material in the proximal balloon cone.An examination of the marker bands identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon with no issues identified.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 a complete break in the hypotube at 62.6 cm distal to the strain relief.
 
Event Description
Reportable based on device analysis completed on 19jan2022.It was reported that the balloon opened abnormally and could not be cut.A 10/3.75 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon could not be expanded that caused unable to cut.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed a hole in the balloon material in the proximal balloon cone.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was returned in a deflated state.A microscopic examination of the balloon material identified a hole in the balloon material in the proximal balloon cone.An examination of the marker bands identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon with no issues identified.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 a complete break in the hypotube at 62.6 cm distal to the strain relief.
 
Event Description
Reportable based on device analysis completed on 19jan2022.It was reported that the balloon opened abnormally and could not be cut.A 10/3.75 flextome cutting balloon was selected for use.During the procedure, it was noted that the balloon could not be expanded that caused unable to cut.The procedure was completed with another of the same device.There were no patient complications reported.However, device analysis revealed a hole in the balloon material in the proximal balloon cone.
 
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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 Key13509450
MDR Text Key285546663
Report Number2134265-2022-01335
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,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2023
Device Model Number3822
Device Catalogue Number3822
Device Lot Number0025123385
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2020
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 Age70 YR
Patient SexMale
Patient Weight80 KG
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