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

Model Number	SBT-114-100
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: ENDOSCOPIC BITE BLOCK
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9596415
• Report Number: 3005099803-2020-00074
• Device Sequence Number: 2335317
• Product Code: MNK
• UDI-Device Identifier: 00816849010168
• UDI-Public: 00816849010168
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 12/25/2019
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 01/16/2020
• Supplement Report FDA Received Date: 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1