MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEASE POLYP TRAP; BOTTLE, COLLECTION, VACCUM

Model Number	00840253111593
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
"trapease" polyp trap, used during colonoscopy, internal safety screen failed to capture polyp.Polyp found resting in lower chamber.Healthcare worker had to break the polyp trap in order to access the lower chamber and retrieve the polyp for submission to pathology.

• Brand Name: TRAPEASE POLYP TRAP
• Common Device Name: BOTTLE, COLLECTION, VACCUM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752 1234
• MDR Report Key: 18768201
• Report Number: MW5151864
• Device Sequence Number: 6309123
• Product Code: KDQ
• UDI-Device Identifier: 00840253111593
• UDI-Public: (01)00840253111593(11)230505(10)230427
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2024

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
• Device Model Number: 00840253111593
• Device Catalogue Number: STE-298
• Device Lot Number: 230427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White