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

Model Number	M006175253080
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial reporter address 1: (b)(6).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was attempted to be used during a procedure in the ureter, performed on (b)(6) 2022.During the procedure, the pigtail tip was kinked during insertion, and it was not possible to insert smoothly.Another percuflex plus ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a0406 captures the reportable event of stent kinked.Block e1: initial reporter address 1: (b)(6) block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder pig tail was buckled accordion also observed a kink on renal pig tail.Additionally the suture hole was stretched out.A functional evaluation noted that a mandrel of 0,035" pass through stent without resistance.The suture was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it was found that a bladder pig tail was buckled accordion also observed a kink on renal pig tail then saw that suture hole was stretch out.Regarding with found issues, bladder coil buckled accordion and renal coil kink possible happened during the interaction with positioner and pusher with excess of force.Besides according to the evidence, it is possible that operational factors, interaction of the device with the suture string, manipulation or excess of force applied during it use, could have caused the stretch out of the suture hole.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was attempted to be used during a procedure in the ureter, performed on (b)(6), 2022.During the procedure, the pigtail tip was kinked during insertion, and it was not possible to insert smoothly.Another percuflex plus ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.

• 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: 14138112
• Report Number: 3005099803-2022-01938
• Device Sequence Number: 20396605
• Product Code: FAD
• UDI-Device Identifier: 08714729297338
• UDI-Public: 08714729297338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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: 08/11/2024
• Device Model Number: M006175253080
• Device Catalogue Number: 175-253-08
• Device Lot Number: 0028621843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/25/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• 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
• Patient Sex: Unknown