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

Model Number M00568151

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/14/2022

Event Type  malfunction  

Manufacturer Narrative

Device code a0501captures the reportable event of internal bolster detached.

Event Description

It was reported to boston scientific corporation that an endovive securi-t was used during a gastrostomy replacement procedure performed on (b)(6) 2022.During the procedure, while removing the device that was placed back on (b)(6) 2022 it separated.The bolster dislodged in the stomach.There was no removal attempt to get the bolster as the physician felt it would pass naturally.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6 (device codes): device code a0501captures the reportable event of internal bolster detached.Block h10: an endovive securi-t percutaneous replacement bolster was returned.Visual analysis of the device revealed the tube was without internal bolster and was not returned.Media inspection showed the internal bolster detached and has remnants of use.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to the manipulation or anatomical conditions of the patient could have contributed to the separation.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 event which led to the reported event.

Event Description

It was reported to boston scientific corporation that an endovive securi-t was used during a gastrostomy replacement procedure performed on (b)(6) 2022.During the procedure, while removing the device that was placed back on (b)(6) 2022 it separated.The bolster dislodged in the stomach.There was no removal attempt to get the bolster as the physician felt it would pass naturally.The procedure was completed with another of the same 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: 16098655
• MDR Text Key: 306845520
• Report Number: 3005099803-2022-07874
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K961345
• 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: 02/22/2023

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 Expiration Date: 10/15/2022
• Device Model Number: M00568151
• Device Catalogue Number: 6815
• Device Lot Number: 0024615934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 01/04/2023
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2019
• 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