MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number SBC-501

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2020

Event Type  Injury  

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 failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr 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 (b)(6) 2020.According to the complainant, during the procedure after passing pediatric forceps down the scope channel the physician noticed a foreign debris inside the patient.A net was used to retrieve the foreign material.They took off the biopsy valve and noted that the debris was from the biopsy valve being fractured.The procedure was completed using the original seal biopsy cap.There were no patient complications reported as a result of this event.

• Brand Name: SEAL BIOPSY VALVE
• Type of Device: 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: 11150070
• MDR Text Key: 226256007
• Report Number: 3005099803-2020-06727
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 08714729981596
• UDI-Public: 08714729981596
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SBC-501
• Device Catalogue Number: 2235-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2020
• 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
• Patient Outcome(s): Required Intervention