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

Model Number	M006175253080
Medical Device Problem Codes	Defective Device (2588); Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(4) 2021 based on the date the manufacturer became aware of the event.(b)(4).The returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the coil did not coil properly, confirming the reported complaint related to device damage/defective.Additionally, the proximal bladder pigtail section was buckled/accordion and the suture hole was torn.The suture string was not returned with the device.A functional evaluation noted that a mandrel 0.035" was inserted through the catheter and no resistance was felt.No other problems with the device were noted.The reported event was confirmed.According to the product analysis, the stent was buckled in the bladder pigtail section causing the pigtail to not coil up properly and the suture hole torn.These problems were 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 problems found were evidence that the device was manipulated and that the failures were generated due to the manipulation/handling of the device or due to the interaction with other devices during the procedure.Therefore, the most probable cause of this complaint is "adverse event related to procedure' since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.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 used during an unknown procedure, performed on an unknown date.During the procedure when the guidewire was released, the pigtail did not coil up properly.The device was replaced and the procedure was completed with another of the same device.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.This event has been deemed a reportable event based on the investigation finding of stent coil buckled/accordion and stent torn inside the patient.

• 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: 11739881
• Report Number: 3005099803-2021-01942
• Device Sequence Number: 4244732
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 08/10/2023
• Device Model Number: M006175253080
• Device Catalogue Number: 175-253-08
• Device Lot Number: 0026341938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1