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

Model Number M0061453520

Device Problem Break (1069)

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

Event Date 12/02/2022

Event Type  malfunction  

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2022-07330).It was reported to boston scientific corporation that a percuflex ureteral stent was opened to be used during a ureteroscopy with stent placement performed on (b)(6) 2021.During preparation, it was found that the stent fractured when it was out from the boxes.The procedure was successfully completed with another percuflex ureteral stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).

• Brand Name: PERCUFLEX
• 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: 16064601
• MDR Text Key: 307024963
• Report Number: 3005099803-2022-07327
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K834468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

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
• Device Operator: Health Professional
• Device Model Number: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0029771605
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2022
• Initial Date FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2022
• 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