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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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2019
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the severely calcified superficial femoral artery.A 3.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, at second inflation, it was noted that the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that a balloon rupture occurred.The 100% stenosed target lesion was located in the severely calcified superficial femoral artery.A 3.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use.During the procedure, at second inflation, it was noted that the balloon ruptured.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the patient status post procedure was good.
 
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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 Key9356726
MDR Text Key173513520
Report Number2134265-2019-14276
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/24/2022
Device Model Number24658
Device Catalogue Number24658
Device Lot Number0023242894
Was Device Available for Evaluation? No
Date Manufacturer Received11/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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