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

Model Number SBT-114-100

Device Problem Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/21/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is 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 bite blox was used during an upper endoscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the patient's mouth was moving, a snapping sound was heard.Upon checking, the device was found to be broken.The procedure was completed using the original device.A small amount of bleeding in the patient's mouth was noted, but the bleed was minor and reportedly did not require any treatment.No other patient complications reported, as a result of this event.

Event Description

It was reported to boston scientific corporation that a bite blox was used during an upper endoscopy procedure performed on (b)(6) 2019 according to the complainant, during the procedure, the patient's mouth was moving, a snapping sound was heard.Upon checking, the device was found to be broken.The procedure was completed using the original device.A small amount of bleeding in the patient's mouth was noted, but the bleed was minor and reportedly did not require any treatment.No other patient complications reported, as a result of this event.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the device manufacture date and expiration date is unknown.Block h6: device code 1562 captures the reportable event of bite block material separation.Block h10: a visual analysis of the returned bite blox revealed a crack on the top right side of the device, across the endochoice logo.The lateral openings and the cleats that the strap attaches to were not affected.The piece that enters the patient's mouth was not broken.No pieces detached.No other issues were noted.Based on the evaluation of the device, it is possible that the device could have cracked due to overtightening or excess pressure during the procedure.The reported bleeding could have been due to a minor cut from the broken device or another issue related to the procedure.The broken part of the device was not the piece that should be in the mouth of the patient.Therefore, the most probable cause of the reported event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.A similar complaint search for the lot was not performed because the reported event occurred due to patient interaction of the device and was not related to manufacturing.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.No further review is required at this time.

• Brand Name: BLOX
• Type of Device: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9596415
• MDR Text Key: 189910154
• Report Number: 3005099803-2020-00074
• Device Sequence Number: 1
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Date Manufacturer Received: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1