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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The chronic totally occluded (cto) target lesion was located in the moderately tortuous and mildly calcified left superficial femoral artery (sfa) and left external iliac artery (eia).After placing the 6fr guiding sheath, non-boston scientific guidewires were tried to cross, but failed.Another non-bsc guide wire crossed the lesion, and pre-dilation was performed using 3mm non-bsc and 4mm coyote balloon catheters, and two eluvia devices were placed.Post dilation was then performed with 5x220 sterling otw balloon catheter, and procedure in sfa was completed.Next, when in-stent dilatation was performed using 6.0mmx40mmx135cm (4f) sterling in 8x40 non-bsc in-stent restenosis (isr) in eia, the balloon ruptured before reaching 14 atmospheres on the second inflation.After imaging, stenosis in isr also improved under angiography, and it was also confirmed upon ivus.Since lumen also extended, the procedure was completed up to this point without replacing the device.The target treatment was completed.No patient complications nor injuries reported.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11575330
• Report Number: 2134265-2021-03594
• Device Sequence Number: 3544355
• Product Code: DQY
• UDI-Device Identifier: 08714729122784
• UDI-Public: 08714729122784
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 01/15/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026640165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1