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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS
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BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS Back to Search Results
Model Number 24690
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 12/23/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via contralateral approach.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right common iliac artery.A 8.0mmx20mmx135cm sterling balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The procedure was completed with a 8x20 mustang balloon catheter.There were no patient complications reported.
 
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Brand Name
STERLING
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11099119
Report Number2134265-2020-18615
Device Sequence Number19779746
Product Code DQY
UDI-Device Identifier08714729757498
UDI-Public08714729757498
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K141150
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/30/2020
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 Date11/07/2021
Device Model Number24690
Device Catalogue Number24690
Device Lot Number0022909781
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/24/2020
Initial Report FDA Received Date12/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
GUIDEWIRE: VASALLO; INTRODUCER SHEATH: PARENT 6FR
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