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

Model Number M0061752530

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the stent shaft middle section shaft detached.A microscope inspection observed the suture hole torn.Additionally, the suture string was not returned with the device.No other problems with the device were noted.The reported event of coil detached was not confirmed.According to product analysis, the stent shaft middle section was detached.Stent shaft detached could have been interpreted by the complainant as coil detached.The suture string was not returned and the device was out of the original pouch, it is evidence that the stent was manipulated out of the package.Therefore, the problems found (middle section shaft detached and suture hole torn) that could have been generated by the user or due to the interacting/handling/manipulation of the device with the suture string since the suture was not returned and an improper manipulation during preparation will damage the device.The investigation concluded that 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 Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during the removal of ureteral calculi in the urethra performed on (b)(6) 2021.During preparation, when the physician unpacked the device, it was found that the coil was detached.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 stable.This event has been deemed a reportable event based on the investigation finding of stent shaft detached.

• Brand Name: PERCUFLEX PLUS
• Type of Device: 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: 11923789
• MDR Text Key: 254305076
• Report Number: 3005099803-2021-02525
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: 08714729056812
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2023
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0025433704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 50