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	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via femoral artery.The target lesion was located in the hepatic vein.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during inflation at 8 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications were reported, and patient's status is stable.
Additional Manufacturer Narrative
E1 (b)(6).B5 describe event or problem: updated.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained via femoral artery.The target lesion was located in the hepatic vein.A 4.0mmx20mmx135cm (4f) sterling balloon catheter was advanced for dilation.However, during inflation at 8 atmospheres, the balloon ruptured.The device was removed, and the procedure was completed with another of same device.No patient complications were reported, and patient's status is stable.It was further reported the target lesion was 70% stenosed, non-tortuous and mildly calcified.

• 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: 15624707
• Report Number: 2124215-2022-41432
• Device Sequence Number: 6385951
• Product Code: DQY
• UDI-Device Identifier: 08714729756958
• UDI-Public: 08714729756958
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/26/2022

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: 03/31/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0029153565
• 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: 10/12/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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 Age: 38 YR
• Patient Sex: Female
• Patient Weight: 60 KG