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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24683
Device Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 04/16/2020
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6.0 x200, 135cm charger balloon catheter was advanced for dilation.However, during inflation, the balloon popped inside the patient.It was noted that the balloon was able to be deflated.No further information available.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6.0 x200, 135cm charger balloon catheter was advanced for dilation.However, during inflation, the balloon popped inside the patient.It was noted that the balloon was able to be deflated.No further information available.It was further reported that the 60% stenosed target lesion was located in the non-tortuous and moderately calcified mid superficial femoral artery.The balloon ruptured during the second inflation at 12 atmospheres.The procedure was completed with another balloon and the patient was fine and well.
 
Event Description
It was reported that balloon rupture occurred.The target lesion was located in the superficial femoral artery.A 6.0 x200, 135cm charger balloon catheter was advanced for dilation.However, during inflation, the balloon popped inside the patient.It was noted that the balloon was able to be deflated.No further information available.It was further reported that the 60% stenosed target lesion was located in the non-tortuous and moderately calcified mid superficial femoral artery.The balloon ruptured during the second inflation at 12 atmospheres.The procedure was completed with another balloon and the patient was fine and well.
 
Manufacturer Narrative
Device evaluated by mfr.: a charger 6.0 x200, 135cm was returned for analysis.Blood was identified in the balloon which is indicative of a leak.The returned device was loaded onto a mandrel and attached to an encore inflation unit.Positive pressure was applied, and a pinhole leak was identified approximately 15mm distal from proximal markerband.No other issues were noted.A visual and microscopic examination of the balloon material identified no other issues that could have contributed to the complaint incident.The rated burst pressure for this device is 16 atmospheres as per the print on the hub.A visual and microscopic examination of the markerbands identified no issues which may potentially have contributed to the complaint incident.A visual and tactile examination identified no kinks or damage to the shaft.A visual and tactile examination identified no damage to the tip.No other issues were identified during the product analysis.
 
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Brand Name
CHARGER
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9979248
MDR Text Key188395178
Report Number2134265-2020-05353
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08714729804369
UDI-Public08714729804369
Combination Product (y/n)N
PMA/PMN Number
K112697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 06/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2023
Device Model Number24683
Device Catalogue Number24683
Device Lot Number0025208504
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/19/2020
Date Manufacturer Received05/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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