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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 24715
Device Problems Entrapment of Device (1212); Failure to Advance (2524); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that catheter entrapment on guidewire occurred. Vascular access was obtained via crossover approach. The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery. After the lesion was crossed with a thruway guidewire and pre-dilated with a 4mm balloon, a 6mm x 120mm and 7mm x 120mm eluvia stents were implanted. A 6. 0x150x150 sterling balloon catheter was advanced for post-dilation but severe resistance was encountered when the balloon started to come out from the tip of the 6fr non-bsc sheath and it could not be delivered smoothly into the stent. Delivery was performed while resistance was felt, and inflation of the balloon was performed about 3 times. However, during removal, the balloon was stuck with the guide wire and it could not be removed. Subsequently, the device was removed as a set with the guidewire and the procedure was completed. No patient complications nor injuries 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 CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key11362093
MDR Text Key233050429
Report Number2134265-2021-02151
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K132430
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 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/26/2021
Device Model Number24715
Device Catalogue Number24715
Device Lot Number0025479424
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2020
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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