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

Model Number	0027633396
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a transuretheral lithotomy procedure in the ureter.The event date was not reported.Post procedure, it was reported that there were approximately 30 stents that were found encrusted in the patient's body in two weeks.There were no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2022, based on the date the manufacturer became aware of the event.Medical device problem code a040501 captures the reportable event of stent calcified.
Additional Manufacturer Narrative
Block b3: date of event was approximated to december 01, 2022, based on the date the manufacturer became aware of the event.Block h6: medical device problem code a040501 captures the reportable event of stent calcified.Block h11: blocks b1, b2, b5, h1 and h6 have been updated based on the additional information received on (b)(6) 2023.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a transureteral lihtotomy procedure in the ureter.The event date was not reported.Post procedure, it was reported that there were approximately 30 stents that were found encrusted in the patient's body in two weeks.There were no patient complication reported as a result of this event.Additional information received on (b)(6) 2023, stating the implant dates for the affected stents occurred over several months and not all were performed by the same physician.It was also reported that some of the stents were still able to drain even though they were found encrusted.The patients underwent regular checkups and an unspecified number of patients had medical conditions or medication that could have contributed to the encrustation.Some of the patients underwent diagnostic testing to confirm they had no metabolic or electrolyte problems.The stents were removed earlier than the scheduled dates with the use of pneumatic system to break the stones and encrustation.Some of the stents were reported to have been torn, but with the pneumatic system all pieces of the stents were removed.It was reported that approximately most of the patients experienced symptoms, however the specific symptoms were not provided.No medication or treatment was provided other than removing the stent.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16162298
• Report Number: 3005099803-2023-00034
• Device Sequence Number: 7470183
• Product Code: FAD
• UDI-Device Identifier: 08714729067757
• UDI-Public: 08714729067757
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 07/07/2024
• Device Model Number: 0027633396
• Device Catalogue Number: 175-254
• Device Lot Number: 0027633396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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