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

Model Number M00509161

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  Injury  

Manufacturer Narrative

(device codes): (b)(4).

Event Description

It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy replacement procedure six months ago.During the replacement procedure, on (b)(6) 2022, the internal bolster detached.An endoscopic examination was immediately performed; however, bolster was not found.A new endovive securi-t replacement bolster was placed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): device code a0501 captures the reportable event of internal bolster detached.Block h10: the returned endovive securi-t replacement bolster was analyzed.Upon visual assessment, it was observed that the bolster of the silicon tube was broken.In addition, part of the bolster was missing, and silicone tube contains remnants of use.Therefore the complaint is confirmed for bolster detached.Based on the condition of the returned device, engineers determined that based upon the adhesion traces found in the silicone tube as well as the detachment and damage to the bolster it suggests that the device was subjected to excessive force; perhaps the manipulation, or patient's anatomical conditions could have contributed to this event.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on the event which led to the reported event.

Event Description

It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a percutaneous endoscopic gastrostomy replacement procedure six months ago.During the replacement procedure, on (b)(6) 2022, the internal bolster detached.An endoscopic examination was immediately performed; however, retrieval of detached portion was unsuccessful.A new endovive securi-t replacement bolster was placed.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: 15813605
• MDR Text Key: 303800139
• Report Number: 3005099803-2022-06627
• 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,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509161
• Device Catalogue Number: 0916
• Device Lot Number: 0029548529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 11/28/2022
• Supplement Dates FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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
• Patient Outcome(s): Other