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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 24681
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/23/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age at the time of event: 18 years or older.
 
Event or Problem Description
It was reported that balloon rupture occurred.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified iliac artery.Two 12.0 x40, 75cm charger balloon catheters were used for dilatation consecutively.However, during the initial inflation at 5-6 atmospheres for 3 seconds, the balloons ruptured.Both devices were completely removed from the patient's body and the procedure was completed with a 10mm charger balloon.No patient complications were reported.
 
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Brand Name
CHARGER
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9699338
Report Number2134265-2020-01348
Device Sequence Number16850142
Product Code FGE
UDI-Device Identifier08714729803867
UDI-Public08714729803867
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K112697
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/12/2020
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
Operator of Device Health Professional
Device Expiration Date10/23/2022
Device Model Number24681
Device Catalogue Number24681
Device Lot Number0024654125
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/24/2020
Initial Report FDA Received Date02/12/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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