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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION ATHLETIS PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 39347-080870
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/10/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.An athletis pta balloon dilatation catheter was advanced over a guidewire to de-clot an atrioventricular hemodialysis access graft.When the balloon was inflated to disrupt the interstices of the graft it ruptured at 10 atmospheres.Contrast was seen leaking from the balloon.The balloon was removed from the patient and the procedure was completed successfully using a non boston scientific balloon catheter.There were no patient complications.
 
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Brand Name
ATHLETIS PTA BALLOON DILATATION CATHETER
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12085489
Report Number2134265-2021-08201
Device Sequence Number17111207
Product Code LIT
UDI-Device Identifier08714729974093
UDI-Public08714729974093
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/29/2021
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 Date04/18/2022
Device Model Number39347-080870
Device Catalogue Number39347-080870
Device Lot Number0026219044
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/10/2021
Initial Report FDA Received Date06/29/2021
Patient Sequence Number1
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