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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 02/19/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the calcified right common iliac artery.An 8.0 x40, 75cm charger balloon catheter was advanced for dilation.The balloon was inflated against the lesion at 10 atmospheres for approximately 90 seconds.When the physician went to increase the pressure beyond the nominal pressure, the balloon deflated.Balloon rupture was noted.The device was removed and the procedure was completed.There were no patient complications and no harm was done to the patient.
 
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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 Key9805527
Report Number2134265-2020-02660
Device Sequence Number13616628
Product Code FGE
UDI-Device Identifier08714729804673
UDI-Public08714729804673
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K112697
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/09/2020
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 Date11/06/2022
Device Model Number24681
Device Catalogue Number24681
Device Lot Number0024733031
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/20/2020
Initial Report FDA Received Date03/09/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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