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

Model Number	24716
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the balloon ruptured.The 70% stenosed target lesion was located in the non-tortuous and mildly calcified superficial femoral artery.A 5.0x220x150-hybrid sterling balloon weas advanced for dilation.During the procedure, when the balloon was first inflated at 8 atmospheres, the balloon could not be fully opened and showed a wrinkled shape.Consequently, after adding 2 atmospheres of pressure to 10 atmospheres for 6-8 seconds, the balloon ruptured.The device was removed, and the procedure was completed with another of the same device.No complications were reported, and the patient was stable 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: 19915820
• Report Number: 2124215-2024-47866
• Device Sequence Number: 15479836
• Product Code: LIT
• UDI-Device Identifier: 08714729845409
• UDI-Public: 08714729845409
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K132430
• 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
• Report Date (Section B): 08/06/2024

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: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0033425656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2024
• Initial Report FDA Received Date: 08/06/2024
• Date Device Manufactured: 02/14/2024
• 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