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

Model Number	1094-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that suture detachment occurred.A percuflex was selected for use.During preparation, it was noted that the suture was detached in the package.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 12/01/2023 as the exact event date was not reported.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to (b)(6) 2023 as the exact event date was not reported.Device evaluated by mfr: only the stent was returned for analysis.It was observed that the suture was detached from the stent.Also, the stent was torn.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No other issues were observed in the devices.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that suture detachment occurred.A percuflex was selected for use.During preparation, it was noted that the suture was detached in the package.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 18490400
• Report Number: 2124215-2023-74530
• Device Sequence Number: 3534080
• Product Code: FAD
• UDI-Device Identifier: 08714729032113
• UDI-Public: 08714729032113
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2024

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: 06/05/2026
• Device Model Number: 1094-05
• Device Catalogue Number: 1094-05
• Device Lot Number: 0031766500
• 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: 02/08/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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
• Patient Sex: Unknown