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

Model Number	24700
Medical Device Problem Codes	Difficult to Remove (1528); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon burst and became sheared off, requiring a snare to retrieve.This 3.0x20x150 (4f) sterling balloon was selected for use in a right lower limb crustal vessel percutaneous transluminal angioplasty procedure.There was a short focal anterior tibial (at) occlusion noted via duplex ultrasound.After successful access via the common femoral artery with a 5fr 11cm sheath, the lesion was crossed with a guidewire, then this balloon was inflated across the occlusion at approximately nominal pressure, but immediately burst.Upon attempting to remove the balloon, it felt like it was sticking inside the sheath.It eventually was able to be removed; however, the tip of the balloon had become sheared off.The 5fr sheath was removed and was replaced with a 6fr 45cm sheath over two guidewires.The old sheath was flushed and there was no evidence of balloon material within the sheath.Screening at the level of the at showed the balloon tip was on the guidewire.The wire was snared below the level of the balloon tip after bringing another guidewire below it within the at.The guidewire snared successfully, and the balloon tip was successfully removed.Angiography was performed of the at and no damage was noted.The proximal at lesion required one additional treatment.It was thought that the lesion may have been more calcified than originally understood.There were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this sterling balloon was visually and microscopically examined.Visual examination revealed that the guidewire lumen was separated 151.2cm from the hub.The balloon was separated 154.3cm from the hub.There were multiple kinks to the guidewire lumen on the distal end of the separated piece.Microscopic examination revealed no additional damages.The distal end of the separated balloon was bunched up at the tip.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the clinical observations.
Event or Problem Description
It was reported that the balloon burst and became sheared off, requiring a snare to retrieve.This 3.0x20x150 (4f) sterling balloon was selected for use in a right lower limb crustal vessel percutaneous transluminal angioplasty procedure.There was a short focal anterior tibial (at) occlusion noted via duplex ultrasound.After successful access via the common femoral artery with a 5fr 11cm sheath, the lesion was crossed with a guidewire, then this balloon was inflated across the occlusion at approximately nominal pressure, but immediately burst.Upon attempting to remove the balloon, it felt like it was sticking inside the sheath.It eventually was able to be removed; however, the tip of the balloon had become sheared off.The 5fr sheath was removed and was replaced with a 6fr 45cm sheath over two guidewires.The old sheath was flushed and there was no evidence of balloon material within the sheath.Screening at the level of the at showed the balloon tip was on the guidewire.The wire was snared below the level of the balloon tip after bringing another guidewire below it within the at.The guidewire snared successfully, and the balloon tip was successfully removed.Angiography was performed of the at and no damage was noted.The proximal at lesion required one additional treatment.It was thought that the lesion may have been more calcified than originally understood.There were no patient complications.

• 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: 17623629
• Report Number: 2124215-2023-45303
• Device Sequence Number: 20363206
• Product Code: LIT
• UDI-Device Identifier: 08714729860099
• UDI-Public: 08714729860099
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K141112
• 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): 11/15/2023

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: 10/05/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030289875
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown