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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 Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/30/2019
Event Type  malfunction  
Event Description
It was reported that the balloon detached from the catheter.A 15/4.00 flextome cutting balloon was selected for use.Upon removal of the plastic shield from the balloon's end, it was noted that the balloon separated from the catheter.The device could not be used.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The balloon protector of the device was not returned for analysis.A visual examination identified that the balloon material was completely detached from the device at both distal and proximal balloon bonds.The balloon material, including all blades, was not returned for analysis.A microscopic examination identified that the shaft was kinked at more than one location.A visual and microscopic investigation identified no damage or any issues with the markerbands of the device that could have contributed to the complaint incident.A visual and tactile examination found the hypotube of the device to be kinked at more than one location.The type of damage noted is consistent with excessive force being applied to the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that the balloon detached from the catheter.A 15/4.00 flextome cutting balloon was selected for use.Upon removal of the plastic shield from the balloon's end, it was noted that the balloon separated from the catheter.The device could not be used.There were no patient complications reported.
 
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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
MDR Report Key8955649
MDR Text Key156297652
Report Number2134265-2019-10453
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
PMA/PMN Number
P950020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/20/2020
Device Model Number3824
Device Catalogue Number3824
Device Lot Number0020794537
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Initial Date Manufacturer Received 08/07/2019
Initial Date FDA Received09/03/2019
Supplement Dates Manufacturer Received01/24/2020
Supplement Dates FDA Received01/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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