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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 24630
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2019
Event Type  malfunction  
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified limb.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at nominal pressure.The device was then simply pulled out from the patient's body and the procedure was completed with a different device.There were no complications reported and the patient's condition was good post procedure.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that there was blood in the balloon material which suggests that there is a leak in the device.The returned device was attached to an encore inflation device and subjected to positive pressure, liquid was observed to be leaking from a balloon pinhole located in the mid-section of balloon material.An examination of the balloon material identified no issues which could potentially have contributed to this complaint.A visual and tactile examination of the hypotube was completed.No damage or any issues were noted with the hypotube that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.No damage or any issues were noted with the polymer extrusion shaft that could have contributed to the complaint incident.A visual and microscopic examination of the markerbands was completed.There was no burrs or uneven edges observed on the markerbands.No damage or any issues were noted with the markerbands that could have contributed to the complaint incident.No damage or any issues were noted with the tip that could have contributed to the complaint incident.A visual and microscopic examination observed no damage to the tip or blades.All blades were intact and fully bonded to the balloon surface.No damage or any issues were noted with the blades that could have contributed to the complaint incident.No other issues were identified during the product analysis.
 
Event Description
It was reported that a balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified limb.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at nominal pressure.The device was then simply pulled out from the patient's body and the procedure was completed with a different device.There were no complications reported and the patient's 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 Key9359908
MDR Text Key173506612
Report Number2134265-2019-14314
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 12/05/2019
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 Model Number24630
Device Catalogue Number24630
Device Lot Number0023541371
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/19/2019
Date Manufacturer Received12/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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