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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 Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2022
Event Type  malfunction  
Event Description
It was reported that balloon rupture occurred.A 6.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon burst.There were no any fragments left inside the patient and the device was removed intact.Since the balloon was defective, the physician had to use another device to complete the procedure.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
Date of event: used the first day of the month of the bsc aware date since event date was not provided.(b)(6).
 
Manufacturer Narrative
(b5) describe event or problem: updated to include new information obtained.(b3) date of event: used the first day of the month of the bsc aware date since event date was not provided.(e1) initial reporter address 1: (b)(6).
 
Event Description
It was reported that balloon rupture occurred.A 6.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during procedure, it was noted that the balloon burst.There were no any fragments left inside the patient and the device was removed intact.Since the balloon was defective, the physician had to use another device to complete the procedure.There were no patient complications nor injuries reported.It was further reported that the target lesion was located in the lower leg.The device was simply pulled out.
 
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Brand Name
STERLING
Type of Device
CATHETER, 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
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key16033434
MDR Text Key308010441
Report Number2124215-2022-54249
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24700
Device Catalogue Number24700
Device Lot Number0030207858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/14/2022
Initial Date FDA Received12/22/2022
Supplement Dates Manufacturer Received12/21/2022
Supplement Dates FDA Received12/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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