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

Model Number	24715
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	01/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon detachment and perforation occurred requiring additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).Following a rotational atherectomy procedure, a 6.0x150x150-hybrid sterling balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres for 1 minute, the center part of the balloon ruptured which caused the balloon to split in half and came detached from the balloon catheter which made a small perforation in sfa with mild bleeding.The balloon was fully deflated for 30 seconds and was pulled out.It was realized that half of the balloon was still inside patient.A snare was used to capture, and removed the detached device fragment completely.Ballooning and stenting over the area of perforation were performed to address perforation and completed the procedure successfully.The patient status was good post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr.: 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 balloon is separated 90cm from the tip.The guidewire lumen is separated 138.8cm from the hub and 3mm from the tip.There is a piece of the guidewire lumen that measures approximately 26.7cm long.The proximal marker band is missing.There is buckling to both ends of the separated guidewire lumen piece.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found confirmed the reported separation.
Event or Problem Description
It was reported that balloon detachment and perforation occurred requiring additional intervention.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery (sfa).Following a rotational atherectomy procedure, a 6.0x150x150-hybrid sterling balloon catheter was advanced for dilatation.However, during inflation at 10 atmospheres for 1 minute, the center part of the balloon ruptured which caused the balloon to split in half and came detached from the balloon catheter which made a small perforation in sfa with mild bleeding.The balloon was fully deflated for 30 seconds and was pulled out.It was realized that half of the balloon was still inside patient.A snare was used to capture and removed the detached device fragment completely.Ballooning and stenting over the area of perforation were performed to address perforation and completed the procedure successfully.The patient status was good post-procedure.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16368634
• Report Number: 2124215-2023-04162
• Device Sequence Number: 12648334
• Product Code: LIT
• UDI-Device Identifier: 08714729845447
• UDI-Public: 08714729845447
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• 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
• Report Date (Section B): 03/10/2023

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: 11/28/2025
• Device Model Number: 24715
• Device Catalogue Number: 24715
• Device Lot Number: 0030619460
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• 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; Other
• Patient Sex: Female
• Patient Race: White