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

Model Number M0061752630

Device Problems Calcified (1077); Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problems Sepsis (2067); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  Injury  

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: ried im innkreis, oberosterreich 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.

Event 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.After three months of being implanted, during a planned stone removal, it was noted that the stent was found encrusted with a donut type in the middle and the patient developed sepsis.It was mentioned that a laser was used to remove the encrustation, and it took them four hours to remove the stent using a standard 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.There were no patient complications reported as a result of this event.

Event 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.After three months of being implanted, during a planned stone removal, it was noted that the stent was found encrusted with a donut type in the middle and the patient developed sepsis.It was mentioned that a laser was used to remove the encrustation, and it took them four hours to remove the stent using a standard 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.There were no patient complications reported as a result of this event.Additional information received that the problem happened with a timespan within the last six months.

Manufacturer Narrative

Block b3: date of event was approximated to november 1, 2023, based on the date the manufacturer became aware of the event.Block e1: initial reporter city: ried im innkreis, oberosterreich 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.Update to block b5: additional information received on 01dec2023, that the problem happened with a timespan within the last six months.

Event 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.After three months of being implanted, during a planned stone removal, it was noted that the stent was found encrusted with a donut type in the middle and the patient developed sepsis.It was mentioned that a laser was used to remove the encrustation, and it took them four hours to remove the stent using a standard 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.There were no patient complications reported as a result of this event.Additional information received that the problem happened with a timespan within the last six months.

Manufacturer Narrative

Block b3: date of event was approximated to november 1, 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.Update to block f10, block h6: patient code of sepsis.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18315318
• MDR Text Key: 330326590
• Report Number: 2124215-2023-68514
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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,Followup,Followup
• Report Date: 05/30/2024

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
• Device Operator: Health Professional
• Device Model Number: M0061752630
• Device Catalogue Number: 175-263
• Device Lot Number: 0030582363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2023
• Initial Date FDA Received: 12/12/2023
• Supplement Dates Manufacturer Received: 12/01/2023; Not provided
• Supplement Dates FDA Received: 12/26/2023; 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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