MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number SBC-501

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(b)(6).(b)(4).Investigation results: a seal biopsy cap was received for analysis, a visual evaluation of the returned device revealed a small tear in the opening on the lid of the cap, where devices are passed through.No other issues were noted.Based on the evaluation of the returned device, it is possible that an instrument larger than the recommended diameter was used in conjunction with the biopsy seal valve.The directions for use (dfu) states: "the seal single use biopsy valve is designed to allow passage of a 3.2 mm device with a closed cap and once the device is removed to seal securely." it is also possible a device was left hanging from the valve, causing the leak that occurred during the case.The directions for use (dfu) states: "do not leave a device hanging from the valve.Doing so can cause the creation of a larger valve slit / hole that can compromise leak management." it is likely that operational factors, such as device handling caused or contributed to the complaint.Therefore, the most probable cause of the reported event is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

Event Description

It was reported to boston scientific corporation that a seal biopsy valve was used on an unknown date.According to the complainant, during preparation, the top part of the biopsy valve opened and sprayed.The procedure was completed using the original seal biopsy valve.No patient complications have been reported as a result of this event.

• Brand Name: SEAL BIOPSY VALVE
• Type of Device: SEAL 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: 9263108
• MDR Text Key: 181815069
• Report Number: 3005099803-2019-05320
• 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: Physician
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2022
• Device Model Number: SBC-501
• Device Catalogue Number: 2235-01
• Device Lot Number: 0013289064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1