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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24703
Medical Device Problem Code Material Rupture (1546)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/28/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a vessel below the knee.Two 3.0 mm x 150 mm x 90 cm sterling sl balloon catheters were advanced for use consecutively.However, both balloons ruptured on initial inflation at 12-14 atmospheres.The devices were removed and the procedure was completed with another of same device.There were no patient complications reported and the patient's status was stable.
 
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Brand Name
STERLING SL
Common Device Name
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10143321
Report Number2134265-2020-07401
Device Sequence Number2461976
Product Code DQY
UDI-Device Identifier08714729782490
UDI-Public08714729782490
Combination Product (Y/N)N
Initial Reporter CountrySN
PMA/510(K) Number
K093720
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) 06/11/2020
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 Date10/29/2021
Device Model Number24703
Device Catalogue Number24703
Device Lot Number0024680422
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/28/2020
Initial Report FDA Received Date06/11/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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