MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Percuflex; catheter, biliary, diagnostic

Model Number	23677334
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction

• Brand Name: Percuflex
• Common Device Name: catheter, biliary, diagnostic
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 50410391
• Report Number: 2124215-2026-45338
• Device Sequence Number: 18750101
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: (01)08714729040279(17)280915(10)37463114
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/22/2026

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: 23677334
• Device Catalogue Number: 145-352
• Device Lot Number: 0037463114
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/22/2026
• Date Device Manufactured: 09/16/2025
• 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: 47 YR
• Patient Sex: Male
• Patient Weight: 143 LB