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	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt in a mildly tortuous and non-calcified right arm.A 5.0mmx60mmx135cm sterling balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications reported and the patient was in good condition.
Additional Manufacturer Narrative
D4: lot number updated to 28585532.D4: expiration date updated to 12/19/2024.D4: unique identifier (udi) # updated to (b)(4).
Event or Problem Description
It was reported that balloon rupture occurred.The target lesion was located in a shunt in a mildly tortuous and non-calcified right arm.A 5.0mmx60mmx135cm sterling balloon catheter was advanced for dilatation.However, during inflation at 6 atmospheres, the balloon ruptured.The device was completely removed and the procedure was completed with a different device.No patient complications reported and the patient was in good condition.

• 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: 17733635
• Report Number: 2124215-2023-49624
• Device Sequence Number: 5820262
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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: 12/19/2024
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0028585532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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 FC3 235CM; GUIDEWIRE: JUPITER FC3 235CM
• Patient Sex: Unknown