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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 24634
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured and was simply pulled out from the patient's body.The procedure was completed with a different device.No complications were reported, and patient condition was good.
 
Event Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A 5.00mm/2.0cm/135cm peripheral cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured and was simply pulled out from the patient's body.The procedure was completed with a different device.No complications were reported, and patient condition was good.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Based on potential root causes identified, the following attributes were considered during analysis: a visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A red blood like substance in balloon was indicative of a leak.Device analysis identified a longitudinal tear starting at the proximal marker band and extending 12mm distally.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.
 
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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 Key9435089
MDR Text Key175697412
Report Number2134265-2019-15244
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 02/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24634
Device Catalogue Number24634
Device Lot Number0023818770
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/02/2020
Date Manufacturer Received01/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GUIDEWIRE - CRUISE; GUIDEWIRE - CRUISE; INTRODUCER SHEATH - DESTINATION; INTRODUCER SHEATH - DESTINATION
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