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	Vascular Dissection (3160)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon deflation issue and vessel dissection occurred, and removal difficulties were encountered requiring additional intervention.The 75% stenosed target lesion was located in the moderately calcified and non-tortuous common femoral artery.A 5.0mmx40mmx135cm sterling balloon catheter was advanced for dilatation.A 50/50 contrast and saline were used.The balloon was inflated at 14 atmospheres for approximately 20 seconds with no apparent issues.However, when negative pressure was applied for 5 minutes to the encore 26 inflation device, the balloon did not deflate.The physician attempted to deflate the balloon multiple times but with no success.As the balloon was unable to be removed, a micro puncture needle was used to puncture the balloon through the skin into the artery, but the attempt was unsuccessful.Subsequently, the whole system including the sheath and the inflated balloon were removed through the insertion point of artery.The physician re-entered another sheath and a stent was required due to dissection, caused by the previous intervention.The procedure was completed with another balloon.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: 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 and inflation lumen is separated 33.4 cm from the tip.Microscopic examination revealed no additional damages.The proximal section of the device 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 deflation issue and vessel dissection occurred, and removal difficulties were encountered requiring additional intervention.The 75% stenosed target lesion was located in the moderately calcified and non-tortuous common femoral artery.A 5.0mmx40mmx135cm sterling balloon catheter was advanced for dilatation.A 50/50 contrast and saline were used.The balloon was inflated at 14 atmospheres for approximately 20 seconds with no apparent issues.However, when negative pressure was applied for 5 minutes to the encore 26 inflation device, the balloon did not deflate.The physician attempted to deflate the balloon multiple times but with no success.As the balloon was unable to be removed, a micro puncture needle was used to puncture the balloon through the skin into the artery, but the attempt was unsuccessful.Subsequently, the whole system including the sheath and the inflated balloon were removed through the insertion point of artery.The physician re-entered another sheath and a stent was required due to dissection, caused by the previous intervention.The procedure was completed with another balloon.No further patient complications were reported.

• 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: 16908819
• Report Number: 2124215-2023-22793
• Device Sequence Number: 12625485
• Product Code: DQY
• UDI-Device Identifier: 08714729122906
• UDI-Public: 08714729122906
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 10/18/2025
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0030376794
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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