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	09/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion were moderately tortuous and severely calcified.A 3.0mm x 60mm x 135cm sterling balloon catheter was advanced for dilation.However, during initial inflation at 6 atmospheres for 2 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications nor injuries reported, and the patient was in good condition after the procedure.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).Initial reporter city: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).E1: initial reporter city: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion were moderately tortuous and severely calcified.A 3.0mm x 60mm x 135cm sterling balloon catheter was advanced for dilation.However, during initial inflation at 6 atmospheres for 2 seconds, the balloon ruptured.The device was removed and the procedure was completed with another of same device.There were no patient complications nor injuries reported, and the patient was in good condition after the procedure.It was further reported that the anatomical lesion was located in superficial femoral artery.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15538341
• Report Number: 2124215-2022-39253
• Device Sequence Number: 20594603
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: 09/03/2023
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0025964664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/29/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown