MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION HEDGEHOG; ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE

Model Number SBD-289

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2023.During the scope cleaning, the large brush head broke off into the scope.The detached brush was retrieved by pushing out with another hedgehog.The scope cleaning was completed using another of the same device.There was no patient involvement in this event.

Manufacturer Narrative

Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush break.

Manufacturer Narrative

Block d4: this is a non-sterile device with no expiration date.Block h6: imdrf device code a0401 captures the reportable event of brush break.Block h10: investigation results the returned hedgehog dual-end brush was analyzed.Visual evaluation found that the brush head had separated.It was noted that the returned brush had a clean break, and no material defects or deformation was noted at the area where the device separated.No other problems were noted.The reported event was confirmed.It is possible that excessive force/torque caused the brush head to separate from the working length during cleaning.Based on all available information and analysis of the returned device, the most probable cause is unintended use error caused or contributed to event.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

Event Description

It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2023.During the scope cleaning, the large brush head broke off into the scope.The detached brush was retrieved by pushing out with another hedgehog.The scope cleaning was completed using another of the same device.There was no patient involvement in this event.

• Brand Name: HEDGEHOG
• Type of Device: ACCESSORIES, CLEANING BRUSHES, FOR ENDOSCOPE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 11810 wills road; alpharetta GA 30009
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18408567
• MDR Text Key: 331506855
• Report Number: 3005099803-2023-06838
• Device Sequence Number: 1
• Product Code: MNL
• UDI-Device Identifier: 00840253114044
• UDI-Public: 00840253114044
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SBD-289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• 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