MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number	SBC-501-100
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a colonoscopy procedure performed on (b)(6) 2021.During the procedure, when a radial jaw biopsy forceps was passed down the biopsy channel, a piece of the biopsy cap detached and travelled down the scope.It was noted that no fragmented material of the biopsy cap fell inside the patient's body.The procedure was completed with another seal biopsy cap.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a colonoscopy procedure performed on october 06 2021.During the procedure, when a radial jaw biopsy forceps was passed down the biopsy channel, a piece of the biopsy cap detached and travelled down the scope.It was noted that no fragmented material of the biopsy cap fell inside the patient's body.The procedure was completed with another seal biopsy cap.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device problem code a040103 captures the reportable event of device material fragmentation.Block h10: the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

• Brand Name: SEAL BIOPSY VALVE
• Common Device Name: SEAL BIOPSY VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12715333
• Report Number: 3005099803-2021-05565
• Device Sequence Number: 14628714
• Product Code: OCX
• UDI-Device Identifier: 08714729981619
• UDI-Public: 08714729981619
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K182275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2024
• Device Model Number: SBC-501-100
• Device Catalogue Number: 2235-01
• Device Lot Number: 0015170151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 11/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1