MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number	SBC-580-100
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional 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.The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.(b)(4).According to the complainant is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used on an unknown date.According to the complainant, during the procedure, the biopsy cap popped off from the biopsy port of the scope causing fluids to spray everywhere.They were able to complete the case with this device.There was no serious injury nor any adverse patient effects reported as a result of this event.

• Brand Name: SEAL BIOPSY VALVE
• Common Device Name: BIOPSY VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8577746
• Report Number: 3005099803-2019-02322
• Device Sequence Number: 2346701
• Product Code: OCX
• UDI-Device Identifier: 10840253110067
• UDI-Public: 10840253110067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K161167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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 Model Number: SBC-580-100
• Device Catalogue Number: 2095-02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1