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

Model Number	24700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vein in the left forearm.A 6.0mmx60mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 8 atmospheres for 15 seconds, the balloon ruptured.The device was removed, and the procedure was completed with a different device.There were no complications reported and the patient was in good condition post-procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed no damages.Microscopic examination revealed a longitudinal tear in the balloon 6mm from the tip and is approximately 66mm long.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that balloon rupture occurred.The 90% stenosed target lesion was located in a shunt in the moderately tortuous and moderately calcified vein in the left forearm.A 6.0mmx60mmx80cm (4f) sterling balloon catheter was advanced for dilatation.However, during the first inflation at 8 atmospheres for 15 seconds, the balloon ruptured.The device was removed, and the procedure was completed with a different device.There were no complications reported and the patient was in good condition post-procedure.

• Brand Name: STERLING
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18434494
• Report Number: 2124215-2023-74952
• Device Sequence Number: 12654069
• Product Code: DQY
• UDI-Device Identifier: 08714729123811
• UDI-Public: 08714729123811
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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 Model Number: 24700
• Device Catalogue Number: 24700
• Device Lot Number: 0032818796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• 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