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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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BOSTON SCIENTIFIC CORPORATION STERLING SL; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number 24703
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  malfunction  
Manufacturer Narrative
B3: date of event is unknown e1: initial reporter email: (b)(6).
 
Event Description
It was reported that the balloon was difficult to deflate and difficult to remove.This 2.5mm x 120mm x 90cm sterling sl balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure.After use, the balloon would not deflate immediately, and it was complicated to remove it.There was no harm to the patient.
 
Event Description
It was reported that the balloon was difficult to deflate and difficult to remove.This 2.5mm x 120mm x 90cm sterling sl balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure.After use, the balloon would not deflate immediately, and it was complicated to remove it.There was no harm to the patient.It was further reported that the balloon was being used for pre-dilation in a lower extremity thrombectomy.The balloon was able to be fully removed from the patient after it was deflated with difficulty.
 
Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this sterling sl balloon catheter was returned stuck on an unknown introducer sheath.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed that the inflation lumen was stretched 10cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage that would have contributed to the deflation issue.
 
Event Description
It was reported that the balloon was difficult to deflate and difficult to remove.This 2.5mm x 120mm x 90cm sterling sl balloon catheter was selected for use in a percutaneous transluminal angioplasty procedure.After use, the balloon would not deflate immediately, and it was complicated to remove it.There was no harm to the patient.It was further reported that the balloon was being used for pre-dilation in a lower extremity thrombectomy.The balloon was able to be fully removed from the patient after it was deflated with difficulty.
 
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Brand Name
STERLING SL
Type of Device
CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18588537
MDR Text Key333900214
Report Number2124215-2024-02926
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729782445
UDI-Public08714729782445
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K093720
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number24703
Device Catalogue Number24703
Device Lot Number0031751096
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/05/2023
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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