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

Model Number	M006175253050
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned peruflex plus ureteral stent was analyzed, and a visual evaluation noted that stent shaft was detached, the suture hole was torn at the bladder pigtail, and the proximal section has material deformation.A functional evaluation noted that a 0.035 inch mandrel was able to insert through the catheter with no resistance.The suture string was returned unloaded and cut from the device.No other issues with the device were noted.The reported event was confirmed.The stent shaft was detached 7.4 cm from the renal tip.The suture hole was torn and the stent was torn at the bladder pigtail, and the proximal section has material deformation.Additionally, the suture string was not returned with the device.The device has the suture hole ripped/torn, evidence that the stent was manipulated out of the package.Therefore, the problems found (bladder pigtail detached, suture hole torn, material deformation and stent torn material) are problems that could have been generated by the user or due to the interaction of the device with the suture string during an improper device manipulation.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 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteroscopy procedure performed on (b)(6) 2021.During preparation when removing the suture, the stent was torn.The procedure was completed with another of the same device.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 good.This event has been deemed a reportable event based on the investigation finding of stent shaft break.

• 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: 11488167
• Report Number: 3005099803-2021-00982
• Device Sequence Number: 3804236
• Product Code: FAD
• UDI-Device Identifier: 08714729339977
• UDI-Public: 08714729339977
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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
• Report Date (Section B): 03/15/2021

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: 07/13/2023
• Device Model Number: M006175253050
• Device Catalogue Number: 175-253-05
• Device Lot Number: 0026106483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 03/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1