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 11/07/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.

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 on (b)(6) 2022.During the procedure, the internal bolster detached.The procedure was completed with a new endovive securi-t replacement bolster.There were no patient complications reported as a result of this 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 on (b)(6), 2022.During the procedure, the internal bolster detached.The procedure was completed with a new endovive securi-t replacement bolster.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h2 (additional information): block d4 (lot number, expiration date) and block h4 (device manufacture date) have been updated based on the additional information received on december 7, 2022.Block h6 (device codes): device code a0501 captures the reportable event of internal bolster detached.

Manufacturer Narrative

Block h2 (additional information): block d4 (lot number, expiration date) and block h4 (device manufacture date) have been updated based on the additional information received on december 7, 2022.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.In addition, the inner ring mark on the bolster presumes that it was attached.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.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 percutaneous endoscopic gastrostomy replacement procedure on (b)(6) 2022.During the procedure, the internal bolster detached.The procedure was completed with a new endovive securi-t replacement bolster.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: 15880666
• MDR Text Key: 307594592
• Report Number: 3005099803-2022-07037
• 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,Followup
• Report Date: 01/05/2023

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 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: 11/09/2022
• Initial Date FDA Received: 11/29/2022
• Supplement Dates Manufacturer Received: 12/07/2022; 12/22/2022
• Supplement Dates FDA Received: 12/21/2022; 01/05/2023
• 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