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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
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BOSTON SCIENTIFIC CORPORATION 2CM PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number 24628
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/09/2019
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured.The 75% stenosed target lesion was located in the radial artery.A 6.00mm / 2.0cm / 50cm peripheral cutting balloon was selected for use.During procedure, upon first inflation, the balloon ruptured at 5atm for 1 second and was able to be removed without a problem.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that the balloon ruptured.The 75% stenosed target lesion was located in the radial artery.A 6.00mm / 2.0cm / 50cm peripheral cutting balloon was selected for use.During procedure, upon first inflation, the balloon ruptured at 5atm for 1 second and was able to be removed without a problem.The procedure was completed with another of the same device.No patient complications were reported.It was further reported that the device was simply pulled out from the patient's body and the patient condition was good post procedure.
 
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Brand Name
2CM PERIPHERAL CUTTING BALLOON
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9483040
MDR Text Key176636217
Report Number2134265-2019-15880
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K070951
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/09/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0024084141
Was Device Available for Evaluation? No
Date Manufacturer Received12/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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