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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 24690
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/05/2018
Event Type  malfunction  
Event Description
It was reported that foreign matter was noted on the hoop. The target lesion was located in the mildly tortuous and mildly calcified artery. During unpacking of a 3. 0mmx60mmx135cm (4f) sterling balloon catheter, it was noted that foreign matter found on the hoop. There was no issue with the balloon itself and the procedure was completed using the same device. No patient complications were reported.
 
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Brand NameSTERLING
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8010191
MDR Text Key125280521
Report Number2134265-2018-62341
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K141150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 10/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model Number24690
Device Catalogue Number24690
Device Lot Number0020200419
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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