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

Model Number	24700
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date approximated to (b)(6) 2021 based on date boston scientific was made aware of this event.
Event or Problem Description
It was reported that there was damage to the balloon.A 4.0mmx80mmx80cm sterling balloon was selected for use in a percutaneous transluminal angioplasty procedure.During preparation, the physician noticed the balloon damage and shaft kink and did not use it for the procedure.Another device was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: date approximated to (b)(6) 2021 based on date boston scientific was made aware of this event.
Event or Problem Description
It was reported that there was damage to the balloon.A 4.0mmx80mmx80cm sterling balloon was selected for use in a percutaneous transluminal angioplasty procedure.During preparation, the physician noticed the balloon damage and shaft kink and did not use it for the procedure.Another device was used to complete the procedure.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: 11860328
• Report Number: 2134265-2021-06635
• Device Sequence Number: 1021420
• Product Code: DQY
• UDI-Device Identifier: 08714729123675
• UDI-Public: 08714729123675
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 06/23/2021

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: 02/19/2024
• Device Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0026840758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/23/2021
• Patient Sequence Number: 1