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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 Problems Deflation Problem (1149); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Event Description
It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.An 8.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.Upon deflation, the balloon could not be deflated properly.The device was replaced with another product and completed the procedure.No complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis and completed the investigation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a hole to the inflation lumen 32.3cm from the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage to the device that would have contributed to the reported event.
 
Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis and completed the investigation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a hole to the inflation lumen 32.3cm from the hub.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found no damage to the device that would have contributed to the reported event.
 
Event Description
It was reported that deflation issue occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.An 8.0mmx20mmx80cm (4f) sterling balloon catheter was advanced for dilatation.Upon deflation, the balloon could not be deflated properly.The device was replaced with another product and completed the procedure.No complications were reported.It was further reported that the target lesion was located in the abdominal aorta.The deflation failure occurred when the device was tested outside the patient before use.
 
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Brand Name
STERLING
Type of Device
CATHETER, PERCUTANEOUS
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 Key18933029
MDR Text Key338337292
Report Number2124215-2024-14236
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08714729720645
UDI-Public08714729720645
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K053116
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2024
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 Number0030897007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GUIDEWIRE USED - THRUWAY; GUIDEWIRE USED - THRUWAY; INFLATION DEVICE - BOSTON ANCHOR; INFLATION DEVICE - BOSTON ANCHOR; INTRODUCER SHEATH - TERUMO/GOA; INTRODUCER SHEATH - TERUMO/GOA
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