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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 Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluation by mfr: returned product consisted of a sterling balloon catheter. The outer shaft, inner shaft, balloon and tip were visually and microscopically examined. Visual examination revealed no damages. Microscopic examination revealed a pinhole 1. 1cm from the tip. The device was tracked over a test guidewire and there were no issues. Inspection of the remainder of the device presented no other damage or irregularities.
 
Event Description
Reportable based on device analysis completed on 01-mar-2022. It was reported that balloon damage occurred. The target lesion was located in the right leg angiogram. A 6. 0x220x150 sterling balloon catheter was advanced for dilation. The physician was attempting to plasty a diseased portion of superficial femoral artery prior to ivus imaging to be certain the catheter would track. Unfortunately, the balloon at some point in the lesion was defective. The physician utilized another shorter balloon catheter and a ranger dcb to complete the case without issue. No patient complications were reported. However, returned device analysis revealed balloon pinhole.
 
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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 Key13866012
MDR Text Key288032803
Report Number2134265-2022-02442
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
Report Date 03/22/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number24716
Device Catalogue Number24716
Device Lot Number0027696202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2021
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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