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

Model Number	M0061752730
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state: (b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a right antegrade ureteric stenting procedure in the kidney, ureter and bladder (kub) performed on (b)(6) 2020.According to the complainant, during the procedure, inside the patient, after multiple attempts of advancing the device, the physician found that the stent was crumbled.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block e1: initial reporter state: sg.Block h6: medical device problem code a040601 captures the reportable event of stent buckled/accordion inside the patient.Block h10: the returned percuflex plus ureteral stent was analyzed.The proximal (bladder pigtail section) was buckled/accordion, and was returned with the suture string loaded and the suture hole torn.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the stent has buckled at the bladder pigtail section.This issue is known to be generated due to the force used when the stent is pushed up with the pusher/positioner over the guidewire or when the stent was used.The device was received with the suture string loaded and the suture hole torn.This is evidence that the device was manipulated; therefore, it is most likely that the issue was due to the manipulation of the device or due to the interaction with other devices during the procedure.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on the event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a right antegrade ureteric stenting procedure in the kidney, ureter and bladder (kub) performed on (b)(6) 2020.According to the complainant, during the procedure, , inside the patient, after multiple attempts of advancing the device, the physician found that the stent was crumbled.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.See investigation for results.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11178861
• Report Number: 3005099803-2021-00124
• Device Sequence Number: 11320640
• Product Code: FAD
• UDI-Device Identifier: 08714729041207
• UDI-Public: 08714729041207
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2021

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: 06/01/2023
• Device Model Number: M0061752730
• Device Catalogue Number: 175-273
• Device Lot Number: 0025550059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1