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

Model Number	M006175253190
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a stent placement procedure, a perculfex plus stent was going to be used.During unpacking, the physician found that the stent was broken into two pieces.The procedure was completed with an alternative method.No patient complications were reported.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the returned percuflex plus ureteral stent was analyzed, during the inspection, it was found that the suture hole torn until the tip.Visual and microscopic inspection found a tear near the bladder coil probably caused by the suture.The reported event of stent shaft break could not be confirmed.It was not possible to identify any evidence of the alleged malfunction on the device since no breaks were found on the stent shaft.Also, the evidence from the product record review did not identify a potential product quality issue or new patient harm.Additionally, the problems found could have been caused due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during the setting up.Consequently, affecting the performance of the device.The instructions for use indicates that the suture string/retrieval line is intended to be removed before procedure, the retrieval line may be cut prior to stent placement.Based on the analysis results, the most probable cause is failure to follow instruction since the failure reported was traced to the user not following the manufacturer's instructions.Correction to field block g2 report source (other).
Event or Problem Description
It was reported that, during a stent placement procedure, a perculfex plus stent was going to be used.During unpacking, the physician found that the stent was broken into two pieces.The procedure was completed with an alternative method.No patient complications were reported.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: PERCUFLEX PLUS
• 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: 20820883
• Report Number: 2124215-2024-75606
• Device Sequence Number: 15664382
• Product Code: FAD
• UDI-Device Identifier: 08714729765745
• UDI-Public: 08714729765745
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: M006175253190
• Device Catalogue Number: M006175253190
• Device Lot Number: 0034303367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2024
• 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