MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number SBC-501-100

Device Problem Material Fragmentation (1261)

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

Event Date 10/06/2021

Event Type  malfunction  

Event 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.

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 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.

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
• Type of Device: SEAL BIOPSY VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12715333
• MDR Text Key: 281410449
• Report Number: 3005099803-2021-05565
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 08714729981619
• UDI-Public: 08714729981619
• Combination Product (y/n): N
• PMA/PMN Number: K182275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 10/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1