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

Model Number M0061751970

Device Problems Difficult to Advance (2920); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).(b)(4).The returned flexima biliary delivery system was analyzed, and a visual evaluation noted that the stent shaft and both coils were buckled.Additionally, the positioner was returned in good conditions, however the suture was not returned.During magnification, it was observed closely the buckled accordion.Also observed that the device has several torn along the stent.No other problems with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.According to all gathered information and evidence of both coils buckled accordion, as well as the stent shaft and several torn along the stent.Therefore, it is possible to conclude that the torn found in the device were caused due to an excess of force applied to the device when it was tried to be inserted over the guide wire, such as the handling of the device during the procedure could have contributed to the issue.Therefore, all compiled information on this investigation determines that the most probable cause is "adverse event related to procedure" since the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific corporation that a percuflex plus stent was used during a ureteral stent implantation procedure in the ureter performed on (b)(6) 2022.During the procedure, when the stent was tried to deliver, the stent was folded.The procedure was successfully completed with another percuflex plus biliary stent.There were no patient complications reported as a result of this event.Investigation results revealed that the stent buckled, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

• Brand Name: PERCUFLEX PLUS
• Type of Device: 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16117720
• MDR Text Key: 308617959
• Report Number: 3005099803-2022-07791
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729067603
• UDI-Public: 08714729067603
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Model Number: M0061751970
• Device Catalogue Number: 175-197
• Device Lot Number: 0026430504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Date Device Manufactured: 11/27/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Sex: Male
• Patient Weight: 12 KG