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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 24700
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Perforation of Vessels (2135)
Date of Event 11/24/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6).
 
Event or Problem Description
It was reported that vessel perforation occurred.The 90% stenosed, target lesion was located in a shunt in a severely tortuous forearm vessel.A 6.0mmx100mmx80cm sterling balloon catheter was advanced for use.However, when dilatation at 6 atmospheres was performed, the vessel ruptured and bleeding occurred.After that, long inflation at 2 atmospheres was performed and stopped the bleeding.However, physician believed that balloon might be stretched and over inflated.The procedure was completed with the original device.There were no patient complications.
 
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Brand Name
STERLING
Common Device Name
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key11015674
Report Number2134265-2020-17447
Device Sequence Number11748362
Product Code DQY
UDI-Device Identifier08714729123699
UDI-Public08714729123699
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K053116
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) 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/26/2022
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0023547952
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/01/2020
Initial Report FDA Received Date12/16/2020
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
GUIDE WIRE: FUGA
Outcome Attributed to Adverse Event Required Intervention;
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