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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 06/02/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 100% stenosed target lesion was located in a moderately tortuous and moderately calcified coronary artery.A 10.0mmx40mmx80cm (5f) sterling balloon catheter was advanced for dilation.However, during second inflation at 6 atmospheres for 30 seconds, the balloon ruptured.The device was removed and a balloon pinhole was noted.The procedure was completed with a different device.There were no patient complications reported and the patient status was good.
 
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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 Key12018226
Report Number2134265-2021-07818
Device Sequence Number17302456
Product Code DQY
UDI-Device Identifier08714729720799
UDI-Public08714729720799
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,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/17/2021
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 Date09/21/2021
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0022691377
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/03/2021
Initial Report FDA Received Date06/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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