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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS Back to Search Results
Model Number 24658
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 07/09/2019
Event Type  malfunction  
Event Description
It was reported that a balloon shaft fracture occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, the blue protective cap was tight and difficult to removed.Subsequently, when it was attempted to remove the balloon shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that a balloon shaft fracture occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During preparation, the blue protective cap was tight and difficult to removed.Subsequently, when it was attempted to remove the balloon shaft was fractured.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.The device was received in two sections as a result of a break in the shaft polymer extrusion.The shaft polymer extrusion was inspected.A visual and tactile examination identified a complete break in the shaft polymer extrusion.The break was located 1170mm distal to the distal end of the strain relief.Stretching was evident at the break site.This type of damage is consistent with excessive force being applied to the delivery system.No other issues were noted with the shaft that may have contributed to the complaint incident.In the balloon the blue protective cap was still attached to the balloon.The balloon protector was easily removed from the device with no issues noted.No issues were observed with the balloon material.The balloon and blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.There was no issue noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination no issues with the hypotube.
 
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Brand Name
SMALL PERIPHERAL 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 Key8822713
MDR Text Key152076198
Report Number2134265-2019-08620
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,distri
Type of Report Initial,Followup
Report Date 08/20/2019
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 Health Professional
Device Expiration Date04/18/2022
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0023668766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2019
Initial Date Manufacturer Received 07/09/2019
Initial Date FDA Received07/24/2019
Supplement Dates Manufacturer Received07/30/2019
Supplement Dates FDA Received08/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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