MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSOR; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number M0066703121

Device Problem Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(evaluation conclusion codes): the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a sensor wire was used during a ureteroscopy (urs) procedure performed on (b)(6) 2021.During the procedure, when the device was opened, an orange piece of plastic was found inside the packaging.The procedure was completed with a new sensor wire.There were no reported patient complications as a result of this event.

• Brand Name: SENSOR
• Type of Device: STYLET FOR CATHETER, GASTRO-UROLOGY
• 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: 11849635
• MDR Text Key: 251462654
• Report Number: 3005099803-2021-02240
• Device Sequence Number: 1
• Product Code: EZB
• UDI-Device Identifier: 08714729257349
• UDI-Public: 08714729257349
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2023
• Device Model Number: M0066703121
• Device Catalogue Number: 670-312
• Device Lot Number: 0026278007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2020
• 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