MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE LOW PROFILE REPLACEMENT BUTTON; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568190

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/27/2022

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide physician information, the reported healthcare facility is: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that an endovive low profile replacement button was used during a gastrostomy replacement procedure on (b)(6) 2022.During the procedure, as the device was being stretched, the internal bolster was detached.The procedure was completed with a new endovive low profile replacement button.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: the complainant was unable to provide physician information, the reported healthcare facility is: (b)(6).Block h6 (device codes): device code a0501 captures the reportable event of internal bolster detached.H10: the returned endovive low profile replacement button dome was analyzed.Visual analysis of the device revealed button dome was ruptured by the rod.Therefore, the reported complaint is not confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be due to excessive force that may have been applied when using the obturator; perhaps the technique used, or patient's anatomical conditions could have contributed to this event.Since the investigation findings do not lead to a clear conclusion about the cause of the reported event, cause not established is selected as the most probable cause for the complaint.

Event Description

It was reported to boston scientific corporation that an endovive low profile replacement button was used during a gastrostomy replacement procedure on (b)(6), 2022.During the procedure, as the device was being stretched, the internal bolster was detached.The procedure was completed with a new endovive low profile replacement button.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE LOW PROFILE REPLACEMENT BUTTON
• 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: 16199693
• MDR Text Key: 307706016
• Report Number: 3005099803-2023-00075
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/22/2023

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 Model Number: M00568190
• Device Catalogue Number: 6819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/28/2023
• Supplement Dates FDA Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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