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	12/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via crossover approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After the lesion was crossed with a jupiter fc guidewire and inflated with a 3mm non-boston scientific balloon, a 5.0mmx60mmx135cm sterling balloon catheter was advanced to pre-dilate the lesion.However, during first inflation at 6 atmospheres (atm), the balloon ruptured.An attempt was made to expand with a 5.0 x 40, 135cm mustang balloon catheter, but the balloon also ruptured during first inflation at 10 atm.The device was removed and the procedure was completed with a non-bsc device.No patient complications were reported.
Additional Manufacturer Narrative
E1.Initial reporter first name- updated.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via crossover approach.The 99% stenosed target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.After the lesion was crossed with a jupiter fc guidewire and inflated with a 3mm non-boston scientific balloon, a 5.0mmx60mmx135cm sterling balloon catheter was advanced to pre-dilate the lesion.However, during first inflation at 6 atmospheres (atm), the balloon ruptured.An attempt was made to expand with a 5.0 x 40, 135cm mustang balloon catheter, but the balloon also ruptured during first inflation at 10 atm.The device was removed and the procedure was completed with a non-bsc 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
• 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: 16097422
• Report Number: 2124215-2022-55310
• Device Sequence Number: 6816794
• Product Code: DQY
• UDI-Device Identifier: 08714729757160
• UDI-Public: 08714729757160
• 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): 01/11/2023

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: 11/03/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0028328850
• 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: 12/26/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: JUPITER FC; GUIDEWIRE: JUPITER FC; INTRODUCER SHEATH: CROSSROAD 6FR; INTRODUCER SHEATH: CROSSROAD 6FR; MICRO CATHETER: EVEREST; MICRO CATHETER: EVEREST
• Patient Sex: Unknown