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	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right superficial femoral artery (sfa).6f non-boston scientific sheath was placed and a guidewire was used to cross the lesion.Following intravascular ultrasound (ivus), a 5.0 mm x 100 mm x 135cm sterling balloon catheter was advanced for dilatation.However, during the initial inflation at 6 atmospheres for 10 seconds, the balloon ruptured.The device was completely removed and was replaced with another of a 5mmx 4cm sterling balloon catheter.Dilatation was was performed without problem and the procedure was completed after angiographic checking was done.No patient complications nor injuries were reported.The patient condition was good.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11443754
• Report Number: 2134265-2021-02996
• Device Sequence Number: 3497083
• Product Code: DQY
• UDI-Device Identifier: 08714729122814
• UDI-Public: 08714729122814
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2021

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: 01/26/2023
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0025106632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1