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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 24694
Device Problems Entrapment of Device (1212); Material Deformation (2976)
Patient Problems Hematoma (1884); Vomiting (2144)
Event Date 03/01/2021
Event Type  Injury  
Event Description
It was reported that device entrapment and removal difficulties were encountered. The patient also experienced vomiting and a hematoma. The 80-95% stenosed, 300mm, complex multilevel heavily calcified target lesion was located in the moderately tortuous femoral popliteal artery. A 6f non-boston scientific sheath and a 300cm, 8cm v-18 control wire were placed. A 4. 0 mm x 220 mm x 150 cm sterling balloon catheter was advanced for dilatation. The balloon was inflated thrice at 14 atmospheres for 2 minutes. The device was then fully deflated. The device was attempted to be removed off the wire. Removal difficulties were encountered. The hypotube of the sterling balloon catheter prolapsed and the hypotube kinked distally as a result from the removal difficulties. The physician removed the entire system intact along with the 6f sheath. It was also reported that the patient experienced a hematoma and vomiting. The physician performed a superficial femoral artery (sfa) recanalization and a computerized tomography scan (ct scan) was performed to rule out retroperitoneal hematoma (rph). The procedure was completed. The patient fully recovered.
 
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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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11507773
MDR Text Key240439290
Report Number2134265-2021-02874
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141150
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/27/2022
Device Model Number24694
Device Catalogue Number24694
Device Lot Number0025944860
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 Received04/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2020
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: 03/17/2021 Patient Sequence Number: 1
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