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

Device Problem Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a blox endoscopic bite block was used during an upper endoscopy procedure performed on (b)(6) 2022.During the procedure, the bite block broke and the patient ended up biting the scope.The patient had some bleeding of her lips and no treatment given as bleeding resolved on its own.The procedure completed using the original bite block.There were no patient complications reported as a result of this event.

Manufacturer Narrative

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.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the upn and lot number; therefore, the manufacture date and expiration date are unknown.Block h6: device code a0413 captures the reportable event of bite blox material separation.Block h10: one bite blox was return in three pieces.A visual analysis was performed and it was found out that the lower bite tray is broken and separated into two pieces.The break left sharp edges on the bottom bite tray.No other visual damage found.The reported complaint was confirmed.Product analysis identified that the device was broken on the bottom bite tray where a patient bites down.It is likely that adverse procedural factors related to patient response may have contributed to the reported event.Based on all gathered information, the adverse event occurred during the procedure and the device had no influence; therefore, the most probable cause of this event is adverse event related to procedure.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lot number and a manufacturing review of the most probable lots did not identify any anomalies or deviations that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that a blox endoscopic bite block was used during an upper endoscopy procedure performed on february 15,2022.During the procedure, the bite block broke and the patient ended up biting the scope.The patient had some bleeding of her lips and no treatment given as bleeding resolved on its own.The procedure completed using the original bite block.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 LTD; no 88 of longxi avenue; zhulin town; changzhou city 21324 1; CH 213241
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13711734
• MDR Text Key: 286869632
• Report Number: 3005099803-2022-01137
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 77 KG