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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
Device Problems Material Rupture (1546); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/30/2022
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred. The target lesion was located in the superficial femoral artery. A 6. 0x220x150-hybrid sterling balloon catheter was selected for use. However, upon opening the package, it was noticed that the balloon was wrapped strangely and twisted on delivery shaft. The balloon was initially inflated but did not inflate properly with a significant waist at the mid point of the balloon. After deflation and re-inflation of the balloon, the wrap/waist resolved. The procedure was completed with a different device. There were no patient complications nor injuries 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 Key14025150
MDR Text Key288792378
Report Number2134265-2022-04061
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0028641002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/07/2022
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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