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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
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/30/2018
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: 18 years or older.
 
Event Description
It was reported that a foreign material was noted in the device. The 90% stenosed target lesion was located in the moderately tortuous and non-calcified shunt vein. A 6. 0mmx40mmx80cm (4f) sterling balloon catheter was advanced for dilatation. However, after the procedure, a black foreign object came out from the guidewire lumen of the balloon. The physician noted it appears to be a peeled portion of the internal coating of the guidewire lumen. There was no sign that the inner pouch got compromised prior to opening the product. 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 Key8103140
MDR Text Key128318636
Report Number2134265-2018-63073
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K053116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/27/2020
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0021313580
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/26/2018 Patient Sequence Number: 1
Treatment
GUIDEWIRE: FUGA; INTRODUCER SHEATH: MOSQUITO 6F
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