MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Model Number	24700
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that deflation issues occurred requiring additional intervention.The patient presented with thrombosis of venous sinus and underwent thrombectomy and angioplasty.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon would not deflate.The physician pulled negative with syringe and pulled back on the shaft to make sure there were no kinks, but the balloon would not deflate.Tried using a suction device but the balloon would still not deflate.A vascular surgeon was called in and cut the shaft of the balloon and then forcefully pulled the balloon through the guide sheath.The device was removed, and the procedure was successfully completed with the original device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft is stretched in multiple locations.The inflation lumen is separated 58.7cm from the hub while the guidewire lumen is separated 58.5cm 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 to the device that could have contributed to the reported event.
Event or Problem Description
It was reported that deflation issues occurred requiring additional intervention.The patient presented with thrombosis of venous sinus and underwent thrombectomy and angioplasty.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon would not deflate.The physician pulled negative with syringe and pulled back on the shaft to make sure there were no kinks, but the balloon would not deflate.Tried using a suction device but the balloon would still not deflate.A vascular surgeon was called in and cut the shaft of the balloon and then forcefully pulled the balloon through the guide sheath.The device was removed, and the procedure was successfully completed with the original device.No patient complications were reported.
Event or Problem Description
It was reported that deflation issues occurred requiring additional intervention.The patient presented with thrombosis of venous sinus and underwent thrombectomy and angioplasty.A 7.0mmx40mmx135cm (4f) sterling balloon catheter was advanced for dilatation.However, during the procedure, the balloon would not deflate.The physician pulled negative with syringe and pulled back on the shaft to make sure there were no kinks, but the balloon would not deflate.Tried using a suction device but the balloon would still not deflate.A vascular surgeon was called in and cut the shaft of the balloon and then forcefully pulled the balloon through the guide sheath.The device was removed, and the procedure was successfully completed with the original device.No patient complications were reported.
Additional Manufacturer Narrative
H6: evaluation conclusion codes: updated.Device evaluated by mfr: the device was returned for analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft is stretched in multiple locations.The inflation lumen is separated 58.7cm from the hub while the guidewire lumen is separated 58.5cm 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 to the device that could have contributed to the reported event.

• Brand Name: STERLING
• Common Device Name: 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 Key: 20761249
• Report Number: 2124215-2024-73919
• Device Sequence Number: 21148258
• Product Code: DQY
• UDI-Device Identifier: 08714729124078
• UDI-Public: 08714729124078
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K053116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0034465902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 11/26/2024; 12/12/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 12/11/2024; 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown