MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS SUREDRIVE; STENT, URETERAL

Model Number M0061457490

Device Problems Entrapment of Device (1212); Material Integrity Problem (2978)

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

Event Date 04/13/2023

Event Type  Injury  

Event Description

It was reported to boston scientific that a percuflex plus ureteral stent was used during stone removal procedure in the kidney, performed on (b)(6) 2023.On (b)(6) 2023, a second procedure to remove stones was performed.During this procedure, it was noticed that the upper coil of the implanted stent was not completely coiled in the pelvis.The physician had difficulty in getting the guidewire through implanted stent to remove the stent and kidney stones.The stent was successfully removed without difficulty and a new percuflex plus ureteral stent was implanted and successfully completed the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a04 captures the reportable event of coil, coil memory during stent removal.

• Brand Name: PERCUFLEX PLUS SUREDRIVE
• Type of Device: STENT, URETERAL
• 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: 16894534
• MDR Text Key: 314818140
• Report Number: 3005099803-2023-02450
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729903031
• UDI-Public: 08714729903031
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K974541
• 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: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061457490
• Device Catalogue Number: 64183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Sex: Male