MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number SBC-501-100

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, 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 that was performed on (b)(6) 2020.According to the complainant, during the procedure, when pulling out a snare, the seal biopsy valve was leaking.The procedure was completed with another seal biopsy valve.There were no patient complications 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: 9861831
• MDR Text Key: 191287364
• Report Number: 3005099803-2020-01153
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 08714729981619
• UDI-Public: 08714729981619
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2023
• Device Model Number: SBC-501-100
• Device Catalogue Number: 2235-01
• Device Lot Number: 0013740578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2020
• 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