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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLOX; ENDOSCOPIC BITE BLOCK
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BOSTON SCIENTIFIC CORPORATION BLOX; ENDOSCOPIC BITE BLOCK Back to Search Results
Model Number SBT-114-100
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/18/2019
Event Type  Injury  
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 blox bite block was used on (b)(6) 2019.According to the complainant, after placing the bite block on the patient's mouth after sedation, a snapping sound was heard.The device was found broken and a fragment fell into the stomach.The broken fragment was removed from the patient's stomach using forceps.Another bite block was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.
 
Manufacturer Narrative
Block d4, h4: 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 bite blox was received for analysis, along with the piece that had reportedly detached.A visual evaluation of the returned device found damage on the top and bottom part of the mouth piece where the device would interact with the patient's teeth.One of the outward facing sides was split through and on the same side of the device the distal tip was broken.No other issues were noted.Based on the evaluation of the returned device, it is most likely that operational factors lead to the user experiencing difficulty while using the device which could have led to the application of excessive pressure on the device, resulting in the scratches, break and split.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 manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr history review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.
 
Event Description
It was reported to boston scientific corporation that a blox bite block was used on (b)(6) 2019.According to the complainant, after placing the bite block on the patient's mouth after sedation, a snapping sound was heard.The device was found broken and a fragment fell into the stomach.The broken fragment was removed from the patient's stomach using forceps.Another bite block was used to complete the procedure.There was no serious injury nor adverse patient effects reported as a result of this event.
 
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Brand Name
BLOX
Type of Device
ENDOSCOPIC BITE BLOCK
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key8625014
MDR Text Key145599494
Report Number3005099803-2019-02564
Device Sequence Number1
Product Code MNK
UDI-Device Identifier00816849010168
UDI-Public00816849010168
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSBT-114-100
Device Catalogue Number60264
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2019
Date Manufacturer Received06/19/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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