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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 04/22/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the left iliac.After stent placement post dilation was performed with a charger balloon catheter (12x40, 12x60 and 10x60).Each charger balloon catheter ruptured.A fourth charger (12x60) was used successfully dilated and the procedure was completed.No patient complications were reported and the patient's status was fine.
 
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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 Key8605248
Report Number2134265-2019-05121
Device Sequence Number3029996
Product Code LIT
UDI-Device Identifier08714729803874
UDI-Public08714729803874
Combination Product (Y/N)N
Initial Reporter StateTX
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) 05/13/2019
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 Date01/31/2022
Device Model Number24681
Device Catalogue Number24681
Device Lot Number0023280965
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/23/2019
Initial Report FDA Received Date05/13/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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