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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a gastrostomy replacement procedure performed on (b)(6), 2023.It was reported that, when extending the tip of the bumper using an obturator, the internal bolster detached.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6) hospital.(b)(6).Block h6 (device codes): imdrf device code (b)(6) captures the reportable event of internal bolster detached.

Manufacturer Narrative

Block e1: this event was reported by the sales representative.The healthcare facility is: (b)(6) hospital phone number:(b)(6) block h6 (device codes): imdrf device code a0501 captures the reportable event of internal bolster detached.Block h10: the returned endovive securi-t replacement bolster device was analyzed.Visual analysis revealed that the obturator rod was in good condition and the stick peg was returned detached from the silicon tube.Microscopic examination confirmed the stick peg was detached from the silicon tube.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of bolster detachment was confirmed.During product analysis it was observed that the stick peg was returned detached from the silicon tube.Based on the condition of the returned device, it is possible that the problem may have occurred due to handling of the device and the technique used during preparation.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a gastrostomy replacement procedure performed on (b)(6) 2023.It was reported that, when extending the tip of the bumper using an obturator, the internal bolster detached.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• 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: 18447537
• MDR Text Key: 332151480
• Report Number: 3005099803-2023-06896
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2024

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: M00509171
• Device Catalogue Number: 0917
• Device Lot Number: 0030842674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2023
• 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