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	03/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the balloon ruptured.A 6mm x 40mm x 135cm sterling balloon catheter was selected for use in an angioplasty procedure.During the procedure, the balloon burst.The balloon was then snared out.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of a sterling balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was contrast and blood in the inflation lumen and balloon, and blood in the guidewire lumen.The balloon was loosely folded.Microscope examination revealed that there was a circumferential tear 2mm distal of the proximal end of the balloon.The inner shaft was separated at the tack weld.Inspection of the remainder of the device, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the balloon ruptured.A 6mm x 40mm x 135cm sterling balloon catheter was selected for use in an angioplasty procedure.During the procedure, the balloon burst.The balloon was then snared out.No further 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: 11499301
• Report Number: 2134265-2021-03367
• Device Sequence Number: 5211529
• Product Code: DQY
• UDI-Device Identifier: 08714729122784
• UDI-Public: 08714729122784
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 05/12/2021

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: 01/07/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026594247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention