MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number	2095-02
Medical Device Problem Codes	Material Fragmentation (1261); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used with a speedband superview super 7 during an esophageal varices - ligation banding procedure in the esophagus performed for the treatment of esophageal varices on (b)(6) 2024.During the procedure, the cap of seal biopsy valve was detached when the physician placed the speedband ligation device onto the biopsy cap.The biopsy cap fell into the working channel of the scope and then inside the patient's body.The fragment was retrieved by the physician using forceps.It was reported that the metal rod of the speedband caused the detachment when it was seated onto the biopsy cap.The procedure was completed with the same original seal biopsy valve.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block h6 (patient codes): imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf device code a040103 captures the reportable event of material fragmentation.

• Brand Name: SEAL BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): NOLATO CONTOUR INC; 660 vandeberg street; baldwin WI 54002
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20907274
• Report Number: 3005099803-2024-06307
• Device Sequence Number: 14483145
• Product Code: OCX
• UDI-Device Identifier: 10840253110067
• UDI-Public: 10840253110067
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2095-02
• Device Catalogue Number: 2095-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 12/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown