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

Model Number	24690
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via crossover approach.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After a non-bsc guidewire crossed the lesion, an opticross 18 vascular imaging catheter was advanced but failed to cross the lesion; therefore, a 3.0mmx60mmx135cm sterling balloon catheter was advanced for dilatation.However, during the initial inflation at 4 atmospheres, the balloon rupture occurred.The procedure was completed with a different device.No patient complications were 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: 12701318
• Report Number: 2134265-2021-13442
• Device Sequence Number: 11103649
• Product Code: DQY
• UDI-Device Identifier: 08714729756897
• UDI-Public: 08714729756897
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K141150
• 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): 10/26/2021

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: 04/22/2023
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0025460838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1