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

Model Number	24690
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment occurred.The 99% stenosed target lesion was located in the not tortuous and severely calcified superficial femoral artery (sfa).A sterling balloon catheter was advanced for dilatation.However, during the procedure the balloon broke.An unsuccessful attempt to remove the detached balloon component was made using a lasso.There were no further patient complications and patient condition was good post-procedure.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned 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 guidewire lumen is separated 133.2cm from the hub.The balloon is separated 138.1cm from the hub.There are multiple kinks to the shaft.Microscopic examination revealed no additional damages.The distal end of the separation did not return for analysis.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that balloon detachment occurred.The 99% stenosed target lesion was located in the not tortuous and severely calcified superficial femoral artery (sfa).A sterling balloon catheter was advanced for dilatation.However, during the procedure the balloon broke.An unsuccessful attempt to remove the detached balloon component was made using a lasso.There were no further patient complications and patient condition was good post-procedure.

• 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: 16234448
• Report Number: 2124215-2023-00581
• Device Sequence Number: 6992660
• Product Code: DQY
• UDI-Device Identifier: 08714729756880
• UDI-Public: 08714729756880
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141150
• 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): 01/16/2024

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 Expiration Date: 10/27/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0030441368
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• 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