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

Model Number SBT-114-100

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

(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 bite block was used in the mouth during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2019.According to the complainant, after placing the bite block in the patient's mouth and after sedation, the patient bit down and the biteblox broke into two pieces.The procedure was completed with another bite blox.There were no patient complications reported as a result of this event.

• 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 LT; 100 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: 9540118
• MDR Text Key: 189885303
• Report Number: 3005099803-2019-06342
• Device Sequence Number: 1
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/02/2020

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: SBT-114-100
• Device Catalogue Number: 60264
• Device Lot Number: 0000190406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 01/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2019
• 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