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

Device Problem Break (1069)

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

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

Block d4: this is a non-sterile device with no expiration date.Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, device manufacture date is unknown.Block h6: imdrf device code a0401 captures the reportable event of brush break.

Event Description

Note: this report pertains to one of three hedgehog devices used in the same procedure.It was reported to boston scientific corporation that a hedgehog double-end brush was used during a scope cleaning on (b)(6) 2023.During scope cleaning, the tips of the three brushes came off.The tips were either trapped in the scope and then retrieved or the tips fell off after removal from the scope.There was no patient involvement in this event.No further information has been obtained despite good faith efforts.

• 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: 18622374
• MDR Text Key: 334319497
• Report Number: 3005099803-2024-00281
• Device Sequence Number: 1
• Product Code: MNL
• 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
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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