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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 24716
Medical Device Problem Code Deflation Problem (1149)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 09/07/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that difficulty deflation occurred.The simple, diffuse target lesion was located in the popliteal artery.A 3.0x220x150 (4f) sterling balloon catheter was advanced for dilatation.However, after the first inflation at nominal pressure, the balloon was difficult to deflate.The balloon was then successfully deflated after excessive efforts of manual pulling.No patient complications were reported and the patient's status was stable.
 
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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 Key7935115
Report Number2134265-2018-61588
Device Sequence Number19253362
Product Code LIT
UDI-Device Identifier08714729860174
UDI-Public08714729860174
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K141112
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) 10/04/2018
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 Date12/29/2019
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0022329362
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/10/2018
Initial Report FDA Received Date10/04/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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