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 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2023 as no event date was reported.Imdrf device code a0501captures 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 percutaneous endoscopic gastrostomy procedure.The procedure date is unknown.It was reported that, one day after placement, the bolster was detached.The procedure was completed with a different device.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 procedure.The procedure date is unknown.It was reported that, one day after placement, the bolster was detached.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block b3 (date of event): date of event was approximated to 01may2023 as no event date was reported.Block h6 (device codes): imdrf device code a0501captures the reportable event of internal bolster detached.Block h10: the returned endovive securi-t replacement bolster was analyzed.Upon visual assessment, the device did not present any visual damage, or any signs of problem and its components were properly positioned.Therefore, the reported complaint cannot be confirmed.Based on the condition of the returned device, engineers determined the reported event bolster - detachment of device or device component was not confirmed because the results of the analysis performed on the returned device showed no evidence of issues or defects.Perhaps the technique used, or patient's anatomical conditions could have contributed to this event, however, there is no objective evidence to determine that the reported event occurs due to a device problem.Boston scientific has determined the most probable cause of this complaint is no problem detected.There is no evidence of a manufacturing issue or design which could have caused influence on the 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: 17065998
• MDR Text Key: 317657753
• Report Number: 3005099803-2023-02935
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• 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: 07/19/2023

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: M00509171
• Device Catalogue Number: 0917
• Device Lot Number: 0029652471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 06/28/2023
• Supplement Dates FDA Received: 07/20/2023
• 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