MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SEAL BIOPSY VALVE

Model Number SBC-501

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2019

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)(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 Description

Report number 3005099803-2019-05823 captures the initial egd procedure on (b)(6) 2019.Report number 3005099803-2019-05821 captures the second event in which the scope with the detached piece of the seal biopsy cap was used.Report number 3005099803-2019-05822 captures the third event in which the detached piece of the seal biopsy cap was discovered inside the scope.It was reported to boston scientific corporation that a seal biopsy valve was used during an esophagogastroduodenoscopy (egd) with banding procedure performed on (b)(6) 2019.According to the complainant, the procedure was accomplished without any problems and was completed using the original seal biopsy cap.During another procedure on (b)(6) 2019, while using the same scope that was used during the egd with banding procedure on (b)(6) 2019, a detached piece of a seal biopsy cap was found stuck inside the scope.The internal part of the biopsy cap had broken off, inside the scope, and became stuck.Reportedly the same scope had been used in one other patient, prior to discovering the detached seal biopsy cap piece, inside the scope channel.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: 9385040
• MDR Text Key: 188577433
• Report Number: 3005099803-2019-05821
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2019
• 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