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

Model Number	24700
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a balloon deflation issue occurred.A 6.0mm x 60mm x 80cm (4f) sterling balloon catheter was advanced for use in a percutaneous transluminal angioplasty procedure.After stent placement, the balloon was used to dilate the stent.However, the balloon did not deflate after the second inflation.The balloon was pulled up until the sheath but could only be extracted after the physician made an additional percutaneous puncture in the insertion area in order to puncture the balloon.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Updated b3: date of event device eval by manufacturer: the sterling balloon catheter was returned for analysis.The outer shaft, inner shaft, balloon, and tip were visually and microscopically examined.Visual examination revealed that the shaft was stretched 8.5cm 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 a balloon deflation issue occurred.A 6.0mm x 60mm x 80cm (4f) sterling balloon catheter was advanced for use in a percutaneous transluminal angioplasty procedure.After stent placement, the balloon was used to dilate the stent.However, the balloon did not deflate after the second inflation.The balloon was pulled up until the sheath but could only be extracted after the physician made an additional percutaneous puncture in the insertion area in order to puncture the balloon.There were no patient complications as a result of this 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: 22127082
• Report Number: 2124215-2025-35111
• Device Sequence Number: 15624124
• Product Code: DQY
• UDI-Device Identifier: 08714729123811
• UDI-Public: (01)08714729123811(17)271108(10)35242557
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 0035242557
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2024
• 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