MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	1094-03
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter tip broke.A percuflex catheter was selected for the index procedure.Before the procedure, it was noted that the guidewire broke the tip of the catheter when removing the guidewire.Another percuflex catheter was used to complete the procedure.There were no patient complications reported.
Event or Problem Description
It was reported that the catheter tip broke.A percuflex catheter was selected for the index procedure.Before the procedure, it was noted that the guidewire broke the tip of the catheter when removing the guidewire.Another percuflex catheter was used to complete the procedure.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluation by manufacturer: it is possible to observed that only the stent was returned for analysis.It is possible to observed that the stent was broken at proximal section.And no more damages were observed.Based on the evidence, the stent break can be confirmed due the device condition.

• Brand Name: PERCUFLEX
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• 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: 18812539
• Report Number: 2124215-2024-12237
• Device Sequence Number: 19913514
• Product Code: FAD
• UDI-Device Identifier: 08714729031819
• UDI-Public: 08714729031819
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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 Model Number: 1094-03
• Device Catalogue Number: 1094-03
• Device Lot Number: 0032746350
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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