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	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.A 5.0mm x 220mm x 150cm (4f) fg sterling mr balloon catheter was advanced for dilation.However, in the middle of the first inflation, the balloon ruptured.The device was successfully removed.A sterling 5.0 mm x 150mm balloon catheter was then advanced as replacement.After that, an opticross imaging catheter was advanced for the intravascular imaging of the lesion, but lost image occurred.Another of the same opticross was advanced and lesion check was performed successfully.The procedure was completed, and no patient complications were reported.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that balloon rupture occurred.The 50% stenosed target lesion was located in a moderately tortuous and severely calcified superficial femoral artery.A 5.0mm x 220mm x 150cm (4f) fg sterling mr balloon catheter was advanced for dilation.However, in the middle of the first inflation, the balloon ruptured.The device was successfully removed.A sterling 5.0 mm x 150mm balloon catheter was then advanced as replacement.After that, an opticross imaging catheter was advanced for the intravascular imaging of the lesion, but lost image occurred.Another of the same opticross was advanced and lesion check was performed successfully.The procedure was completed, and no patient complications were reported.It was further reported that the balloon ruptured at 6 atmospheres or less.
Additional Manufacturer Narrative
E1 - initial reporter address 1:(b)(6).Device evaluated by mfr.: the device was returned for analysis.Returned product consisted of a sterling balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a pinhole in the balloon 104mm from the tip.Inspection of the remainder of the device presented no other damage or irregularities.

• 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: 16343912
• Report Number: 2124215-2023-05511
• Device Sequence Number: 6270934
• Product Code: LIT
• UDI-Device Identifier: 08714729859475
• UDI-Public: 08714729859475
• 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): 02/28/2023

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: 08/28/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0030039149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/25/2023
• Supplement Date Received by Manufacturer: 02/08/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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 Sex: Unknown