MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number SBC-580

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2018

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.The complainant was unable to provide the suspect device lot number; therefore, the expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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/esophagogastroduodenoscopy(egd) procedure on an unknown date.According to the complainant, the biopsy cap was leaking and spraying bodily fluid.It was not reported how the procedure was completed.There was no serious injury nor adverse patient effects reported as a result of this event.

• Brand Name: SEAL BIOPSY VALVE
• Type of Device: BIOPSY VALVE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): NOLATO CONTOUR INC; 660 vandeberg street; ,; baldwin WI 54002
• Manufacturer Contact: carole morley ; 100 boston scientific way; ,; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 8248943
• MDR Text Key: 133104855
• Report Number: 3005099803-2018-62525
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 00840253110060
• UDI-Public: 00840253110060
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161167
• 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: 01/15/2019

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
• Device Operator: Health Professional
• Device Model Number: SBC-580
• Device Catalogue Number: 2095-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2018
• Initial Date FDA Received: 01/15/2019
• 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