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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 Material Rupture (1546)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/26/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in the 100% stenosed target lesion was located in a shunt in the mildly tortuous and moderately calcified vessel in the forearm.A 4.0mmx20mmx40cm (4f) sterling balloon catheter was advanced for dilatation; however, during first inflation, the balloon ruptured at 3 atmospheres.The device was removed without any problem and the procedure was completed with another of same device.There were no complications nor injuries 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 Key11273996
Report Number2134265-2021-01197
Device Sequence Number4228768
Product Code DQY
UDI-Device Identifier08714729123538
UDI-Public08714729123538
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K053116
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/03/2021
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 Date04/29/2023
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0025479423
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/28/2021
Initial Report FDA Received Date02/03/2021
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: KYOUSHA NT; INFLATION DEVICE: EVEREST; INTRODUCER SHEATH: TERUMO SHEATH 6FR
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