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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 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured.The 75% stenosed target lesion was located in the moderately tortuous cephalic vein.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the balloon ruptured upon second inflation at 8atm for several seconds.The device was removed without problem and the procedure was completed.No patient complications were reported.
 
Manufacturer Narrative
E1.Initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.No tears or holes were visible in the balloon.The device was attached to an encore inflation device and positive pressure and a pinhole leak was identified 5mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.All blades were fully bonded onto the balloon with no issues identified.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the markerbands.A visual and tactile examination identified no issues.No other issues were identified during the product analysis.
 
Event Description
It was reported that the balloon ruptured.The 75% stenosed target lesion was located in the moderately tortuous cephalic vein.A 5.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, the balloon ruptured upon second inflation at 8atm for several seconds.The device was removed without problem and the procedure was completed.No patient complications were reported.
 
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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 Key9526560
MDR Text Key177142340
Report Number2134265-2019-16218
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 02/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/19/2021
Device Model Number24630
Device Catalogue Number24630
Device Lot Number0023373338
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Date Manufacturer Received02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE: GT; GUIDEWIRE: GT; INFLATION DEVICE: KANEKA; INFLATION DEVICE: KANEKA; INTRODUCER SHEATH: 6F 3CM; INTRODUCER SHEATH: 6F 3CM
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