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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 11/19/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the balloon ruptured.The 100% stenosed target lesion was in a moderately tortuous and severely calcified superficial femoral artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atm upon third inflation and was removed without any problem.The procedure was completed with another of the same device.No patient complications reported.
 
Manufacturer Narrative
Initial reporter city: (b)(6).
 
Event Description
It was reported that the balloon ruptured.The 100% stenosed target lesion was in a moderately tortuous and severely calcified superficial femoral artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atm upon third inflation and was removed without any problem.The procedure was completed with another of the same device.No patient complications reported.It was further reported that the balloon was simply pulled out of the patient's body and the patient was stable post procedure.
 
Event Description
It was reported that the balloon ruptured.The 100% stenosed target lesion was in a moderately tortuous and severely calcified superficial femoral artery.A 6.00mm/2.0cm/90cm peripheral cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured at 10 atm upon third inflation and was removed without any problem.The procedure was completed with another of the same device.No patient complications reported.It was further reported that the balloon was simply pulled out of the patient's body and the patient was stable post procedure.
 
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.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 3mm proximal of the distal markerband.An examination of the balloon material and markerbands identified no issues which could potentially have contributed to this complaint.The rated burst pressure for this device is 10 atmospheres as per pcb2cm specification.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.A visual and tactile examination identified no kinks or damage to the shaft of the device.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 Key9414138
MDR Text Key175367510
Report Number2134265-2019-14989
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 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number0023482012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2019
Initial Date Manufacturer Received 11/20/2019
Initial Date FDA Received12/04/2019
Supplement Dates Manufacturer Received11/20/2019
01/14/2020
Supplement Dates FDA Received12/05/2019
02/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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