MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00509171

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.Block h6: imdrf device code a0501 captures the reportable event of device component detached.

Event Description

It was reported to boston scientific corporation that a patient with an endovive securi-t replacement bolster experienced a little pain on (b)(6) 2024.It was reported that the device was placed approximately three months before the pain occurred.According to the complainant, the condition of the device was checked, and it was found that one of the t-shaped tips (gastric side) had broken off.It was assumed that the pain was caused by the broken t-shaped tip that was stuck in the fistula.The device was removed from the patient and a new endovive securi-t replacement bolster was inserted.The patient's condition at the conclusion of the procedure was reported to be stable.The patient had a ct scan to determine the location of the detached t-shaped tip, but no such object was found, and it was determined that the fragment was excreted.

• Brand Name: ENDOVIVE SECURI-T
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19092771
• MDR Text Key: 340593060
• Report Number: 3005099803-2024-01534
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509171
• Device Catalogue Number: 0917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• 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