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

Model Number	24690
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 6.0mmx40mmx135cm (4f) sterling balloon was selected for use.However, upon opening the package and removing this device, there was a wire-like object in the inflation lumen.They are being collected together and the procedure was completed with another of the same device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
E1.Initial reporter country was updated to japan.Device evaluated by mfr: the complaint device was received for product analysis.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the core wire is no longer seated inside the hub and is able to freely move.Microscopic examination revealed no additional damages.Operations engineering reviewed the device and confirmed that the core wire is able to move freely but also found a mark inside the hub left by the core wire.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found that the core wire is able to move freely.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device contamination occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified iliac artery.A 6.0mmx40mmx135cm (4f) sterling balloon was selected for use.However, upon opening the package and removing this device, there was a wire-like object in the inflation lumen.They are being collected together and the procedure was completed with another of the same device.No patient complications nor injuries were reported.

• 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: 18489725
• Report Number: 2124215-2023-74843
• Device Sequence Number: 3690461
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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 Expiration Date: 06/07/2025
• Device Model Number: 24690
• Device Catalogue Number: 24690
• Device Lot Number: 0029551733
• 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: 12/20/2023
• Supplement Date Received by Manufacturer: 02/07/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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