MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLOX; ENDOSCOPIC BITE BLOCK

Device Problems Material Separation (1562); Use of Device Problem (1670)

Patient Problem Tooth Fracture (2428)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

Medwatch# mw5102112.The complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown (b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a blox endoscopic bite block was used during a cardioversion procedure performed on (b)(6) 2021.During the procedure, an audible crack was heard however the source was not identified.Upon completion of the procedure it was noted that the bite blox was broken into pieces.The patient complains of a loose tooth, however there was no serious injury or adverse event reported as a result of this event.Note: it was reported that biteblox was used in a cardioversion procedure.However, per the blox endoscopic bite block instructions for use, the device is intended to provide safe passage through the patients mouth during upper endoscopic procedures.The device is not indicated to be used during cardioversion procedures.

• Brand Name: BLOX
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): JIANGSU JIANYU HEALTH MEDICAL CO LTD; zhixi industry zone; jintan area; changzhou city 21325 1; CH 213251
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12328908
• MDR Text Key: 266835706
• Report Number: 3005099803-2021-03919
• Device Sequence Number: 1
• Product Code: MNK
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1