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

Model Number	M0061752620
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	11/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event.Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a040501 captures the reportable event of stent calcified.Imdrf patient code e0306 captures the reportable event of sepsis.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was successfully implanted during a procedure.The event date was unknown.During a planned stone removal, after three months of being implanted, it was noted that the stent was found encrusted and no longer visible.It was mentioned that the stent could not be grasped, so, they used a holmium laser to remove at least enough encrustation from the bladder loop and it took them four hours to remove the stent using a standard stainless-steel gripper.The procedure was successfully completed with a non-boston scientific device.A photo of the complaint device was provided and showed the stent was calcified.The patient suffered from sepsis and is now in the palliative department.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was successfully implanted during a procedure.The event date was unknown.During a planned stone removal, after three months of being implanted, it was noted that the stent was found encrusted and no longer visible.It was mentioned that the stent could not be grasped, so, they used a holmium laser to remove at least enough encrustation from the bladder loop and it took them four hours to remove the stent using a standard stainless-steel gripper.The procedure was successfully completed with a non-boston scientific device.A photo of the complaint device was provided and showed the stent was calcified.The patient suffered from sepsis and is now in the palliative department.Additional information received that the problem happened with a timespan within the last six months.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 2023, based on the date the manufacturer became aware of the event.Block e1: initial reporter city: (b)(6).Block h6: imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf device code a040501 captures the reportable event of stent calcified.Imdrf patient code e0306 captures the reportable event of sepsis.Update to block b5: additional information received on 01dec2023, that the problem happened with a timespan within the last six months.

• 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: 18322966
• Report Number: 2124215-2023-68520
• Device Sequence Number: 20575640
• Product Code: FAD
• UDI-Device Identifier: 08714729056829
• UDI-Public: 08714729056829
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 12/27/2023

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: 01/22/2026
• Device Model Number: M0061752620
• Device Catalogue Number: 175-262
• Device Lot Number: 0030901470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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