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

Model Number	M0061752620
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated based on the date the manufacturer became aware of the event.Block e1: initial reporter city: (b)(6).Block e1: initial reporter phone (b)(6).Block h6: imdrf device code a040501 captures the reportable event of stent calcified.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was being exchange for another stent during a procedure for urology stone treatment.The event date was unknown.It was noted that the stent was placed several months ago.The procedure was successful.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.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block b3: date of event was approximated based on the date the manufacturer became aware of the event.Block e1: initial reporter city: ried im innkreis, oberosterreich block e1: initial reporter phone (b)(6) block h6: imdrf device code a040501 captures the reportable event of stent calcified.Correction to block e1: initial reporter initial reporter first name initial reporter last name initial reporter email correction to block g2: austria.
Event or Problem Description
It was reported to boston scientific that a percuflex plus ureteral stent was being exchange for another stent during a procedure for urology stone treatment.The event date was unknown.It was noted that the stent was placed several months ago.The procedure was successful.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.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 ; 5086834015
• MDR Report Key: 18144768
• Report Number: 2124215-2023-61985
• Device Sequence Number: 15200594
• 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): 03/28/2024

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 Expiration Date: 11/27/2025
• Device Model Number: M0061752620
• Device Catalogue Number: 175-262
• Device Lot Number: 0030607384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2022
• 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