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

Model Number	H74939032401010
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	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon deflation failure occurred.A 4.0mmx100mmx135cm (4f) sterling balloon catheter was advanced for dilation.During the procedure, the balloon was unable to deflate and a great deal of difficulties of removing it from the patient were encountered.
Event or Problem Description
It was reported that balloon deflation failure occurred.A 4.0mmx100mmx135cm (4f) sterling balloon catheter was advanced for dilation.During the procedure, the balloon was unable to deflate and a great deal of difficulties of removing it from the patient were encountered.It was further reported that the sterling balloon catheter was selected for use in the distal superficial femoral artery.The target lesion was 60-70% stenosed with mild calcification and no tortuosity.There was difficulty removing the balloon and it was ultimately removed inflated through the long 6fr sheath.A new sterling balloon was used to complete the procedure.Good clinical results were noted as the procedure outcome, and the patient was discharged the next day as planned.
Additional Manufacturer Narrative
Device eval by mfr: the device was received and analysis completed.The returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft is stretched 94.8cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon deflation failure occurred.A 4.0mmx100mmx135cm (4f) sterling balloon catheter was advanced for dilation.During the procedure, the balloon was unable to deflate and a great deal of difficulties of removing it from the patient were encountered.It was further reported that the sterling balloon catheter was selected for use in the distal superficial femoral artery.The target lesion was 60-70% stenosed with mild calcification and no tortuosity.There was difficulty removing the balloon and it was ultimately removed inflated through the long 6fr sheath.A new sterling balloon was used to complete the procedure.Good clinical results were noted as the procedure outcome, and the patient was discharged the next day as planned.
Additional Manufacturer Narrative
"udi related data quality updates only.This report is being filed as a correction in response to an fda request for the complete the unique identifier (udi) #." device eval by mfr: the device was received and analysis completed.The returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the shaft is stretched 94.8cm from the hub.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon deflation failure occurred.A 4.0mmx100mmx135cm (4f) sterling balloon catheter was advanced for dilation.During the procedure, the balloon was unable to deflate and a great deal of difficulties of removing it from the patient were encountered.It was further reported that the sterling balloon catheter was selected for use in the distal superficial femoral artery.The target lesion was 60-70% stenosed with mild calcification and no tortuosity.There was difficulty removing the balloon and it was ultimately removed inflated through the long 6fr sheath.A new sterling balloon was used to complete the procedure.Good clinical results were noted as the procedure outcome, and the patient was discharged the next day as planned.

• 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: 18377721
• Report Number: 2124215-2023-70156
• Device Sequence Number: 15357760
• Product Code: DQY
• UDI-Device Identifier: 08714729123507
• UDI-Public: (01)08714729123507(17)20260530(10)0031730217
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup,Followup
• Report Date (Section B): 07/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/30/2026
• Device Model Number: H74939032401010
• Device Catalogue Number: 24700
• Device Lot Number: 0031730217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 12/27/2023; 02/07/2024; 07/09/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 01/18/2024; 03/01/2024; 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2023
• 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
• Patient Sex: Unknown