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 12/12/2022

Event Type  Injury  

Manufacturer Narrative

Device code a0501 captures the reportable event of internal bolster detached.

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) 2022.During the replacement procedure, when trying to remove the placed device the bolster dislodged inside the patient.The bolster was retrieved through an endoscope.The procedure was completed with the same original device that was going to be used for replacement.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: the returned endovive securi-t replacement bolster was analyzed.Upon visual assessment, it was observed that silicone tube of the bolster was detached.Therefore, the complaint is confirmed.Based on the condition of the returned device, engineers determined that it is possible that at the time of interact with the device an excess of force has been applied; perhaps the manipulation, or technique used, could have contributed to this event.The bolster has the mark of the inner ring, this is evidence that it was attached in the beginning, so it could have been separated due to excess force and 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.

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) 2022.During the replacement procedure, when trying to remove the placed device the bolster dislodged inside the patient.The bolster was retrieved through an endoscope.The procedure was completed with the same original device that was going to be used for replacement.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: 16120868
• MDR Text Key: 306893730
• Report Number: 3005099803-2022-07893
• 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: 02/21/2023

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: 12/13/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 01/31/2023
• Supplement Dates FDA Received: 02/21/2023
• 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