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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 Problems Material Rupture (1546); Device Dislodged or Dislocated (2923)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Event Description
It was reported that the balloon ruptured.The 100% stenosed target lesion was located in the moderately tortuous shunt.A 5.00mm/2.0cm/50cm peripherial cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured at 6atm upon first inflation for 1 second.The balloon was then simply removed from the patient's body.No complications were reported and the patient's condition was good.
 
Manufacturer Narrative
Lot number updated from 0023758025 to 0023150629.Expiration date updated from 05/07/2021 to 01/07/2021.Unique identifier (udi) # updated from (b)(4) to (b)(4).Device manufacture date 05/08/2019 to 01/08/2019.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.One of the cutting blades was lifted from the balloon material.Analysis noted that approximately 6mm of the cutting blade is still attached to the distal end of the balloon, and the remaining section of blade is lifted upright from the balloon material.All the blade pads were noted to be attached to the balloon material.The returned device was attached to an encore inflation unit.Positive pressure was applied when liquid was observed to be leaking from a balloon pinhole located approximately 1mm distal from the distal edge of the distal markerband.An examination of the balloon material and blades identified no issues which could potentially have contributed to this complaint.No issues were noted with the tip section of the device.A visual and tactile examination identified no issues with the shaft which may have potentially contributed to the complaint incident.
 
Event Description
It was reported that the balloon ruptured.The 100% stenosed target lesion was located in the moderately tortuous shunt.A 5.00mm/2.0cm/50cm peripherial cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured at 6atm upon first inflation for 1 second.The balloon was then simply removed from the patient's body.No complications were reported and the patient's condition was good.It was further reported that the blade was noted lifted after the device was removed from the sheath.It was then further reported that the blade lift occurred after the device was removed from the patient.
 
Manufacturer Narrative
D4.Lot number updated from 0023758025 to 0023150629.D4.Expiration date updated from 05/07/2021 to 01/07/2021.D4.Unique identifier (udi) # updated from (b)(4).H4.Device manufacture date 05/08/2019 to 01/08/2019.
 
Event Description
It was reported that the balloon ruptured.The 100% stenosed target lesion was located in the moderately tortuous shunt.A 5.00mm/2.0cm/50cm peripherial cutting balloon was selected for use.During procedure, it was noted that the balloon ruptured at 6atm upon first inflation for 1 second.The balloon was then simply removed from the patient's body.No complications were reported and the patient's condition was good.It was further reported that the blade was noted lifted after the device was removed from the sheath.
 
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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 Key9219284
MDR Text Key166568383
Report Number2134265-2019-12749
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,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/07/2021
Device Model Number24628
Device Catalogue Number24628
Device Lot Number0023150629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/24/2019
Date Manufacturer Received11/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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