MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number	SBC-365
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the reported event date is (b)(6) 2019.However, the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the event date reported.Lot #, expiration date, manufacture date: the complainant was unable to provide the lot number; therefore, the 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 or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a gastroscopy procedure during (b)(6) 2019.According to the complainant, while taking a biopsy in the stomach, a tiny blue particle was noticed on the set of biopsy forceps that were being used.The forceps were removed from the patient, and the particle was then removed from the forceps and set aside.During another pass, a second blue particle was noticed in the patient's stomach.The second blue particle was retrieved.It was presumed that it came from the biopsy cap, as it was the only blue artificial item in the path of the biopsy forceps.It is unknown how the procedure was completed.There was no serious injury nor adverse patient effects reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.
Additional Manufacturer Narrative
B3, b5 updated.D4 and h4: the complainant was unable to provide the lot number; therefore, the expiration and device manufacture dates are unknown.G3: medwatch number: (b)(4).H6: device code 1261 captures the reportable event of biopsy cap material fragmentation.H10: 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 or Problem Description
It was reported to boston scientific corporation that a seal biopsy valve was used during a gastroscopy procedure during february 2019.According to the complainant, while taking a biopsy in the stomach, a tiny blue particle was noticed on the set of biopsy forceps that were being used.The forceps were removed from the patient, and the particle was then removed from the forceps and set aside.During another pass, a second blue particle was noticed in the patient's stomach.The second blue particle was retrieved.It was presumed that it came from the biopsy cap, as it was the only blue artificial item in the path of the biopsy forceps.It is unknown how the procedure was completed.There was no serious injury nor adverse patient effects reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.Additional information received on 17may2019.Procedure happened on (b)(6) 2019.The procedure was completed with the orignal device.

• 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: 8621343
• Report Number: 3005099803-2019-02549
• Device Sequence Number: 13962918
• Product Code: OCX
• UDI-Device Identifier: 00840253103031
• UDI-Public: 00840253103031
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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: SBC-365
• Device Catalogue Number: 2095-02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 05/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 13 YR
• Patient Weight: 41