MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX; CATHETER, BILIARY, DIAGNOSTIC

Model Number	1094-04
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the marker was detached.A percuflex drainage catheter was selected for use.During the procedure, the marker was found detached, and it took a long time to remove the device from the patient.The physician used another device to remove the catheter.No complications were reported.
Event or Problem Description
It was reported that the marker was detached.A percuflex drainage catheter was selected for use.During the procedure, the marker was found detached, and it took a long time to remove the device from the patient.The physician used another device to remove the catheter.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was not returned for analysis.However, a media inspection was performed with the picture attached.Based on the media inspection results, the reported allegations of stent break could not be confirmed, since the reported issue was not shown in the picture.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19991587
• Report Number: 2124215-2024-49743
• Device Sequence Number: 8461487
• Product Code: FAD
• UDI-Device Identifier: 08714729048633
• UDI-Public: 08714729048633
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K924608
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2026
• Device Model Number: 1094-04
• Device Catalogue Number: 1094-04
• Device Lot Number: 0032065316
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 09/18/2024
• Date Device Manufactured: 07/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown