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

Model Number	24716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained by contralateral approach via groin.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery and popliteal artery (fem-pop) graft.Following laser atherectomy, a 7.0x220150-hybrid sterling balloon catheter was advanced for dilatation.However, during inflation at 3-4 atmospheres, a balloon leak was noted.It was observed that there was a hole in the balloon which would not allow it to reach nominal pressure.The device was removed, and the procedure was completed with a non-boston scientific device.No patient complications were reported.
Event or Problem Description
It was reported that balloon rupture occurred.Vascular access was obtained by contralateral approach via groin.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery and popliteal artery (fem-pop) graft.Following laser atherectomy, a 7.0x220150-hybrid sterling balloon catheter was advanced for dilatation.However, during inflation at 3-4 atmospheres, a balloon leak was noted.It was observed that there was a hole in the balloon which would not allow it to reach nominal pressure.The device was removed, and the procedure was completed with a non-boston scientific device.No patient complications were reported.It was further reported that the balloon was inflated once and was removed via standard pin/pull technique.The patient had no vessel injury and 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: 17698058
• Report Number: 2124215-2023-47796
• Device Sequence Number: 7510351
• Product Code: LIT
• UDI-Device Identifier: 08714729845560
• UDI-Public: 08714729845560
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 05/12/2025
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0029393687
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2022
• 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: 65 YR
• Patient Sex: Female