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	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a catheter break occurred.A percuflex ureteral drainage catheter was selected for use and successfully implanted.It was noted that while the drainage catheter was implanted, the catheter had fractured.While removing the drainage catheter the fractured portion remained inside the patient.Additional intervention using a pliers was performed to retrieve the device fragment.The procedure was cancelled.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for evaluation.It was observed that the stabilizer and the flexible cannula was returned for the analysis, the devices were inspected, and no issues or anomalies were noted.The pouch was returned, and it was observed that the pouch information matches with the complaint information.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that a catheter break occurred.A percuflex ureteral drainage catheter was selected for use and successfully implanted.It was noted that while the drainage catheter was implanted, the catheter had fractured.While removing the drainage catheter the fractured portion remained inside the patient.Additional intervention using a pliers was performed to retrieve the device fragment.The procedure was cancelled.There were no patient complications.

• 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: 18012420
• Report Number: 2124215-2023-59415
• Device Sequence Number: 7469281
• Product Code: FAD
• UDI-Device Identifier: 08714729048633
• UDI-Public: 08714729048633
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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