MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE OSB KIT PULL W/ENFIT 24F 3.4CM; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number M00509670

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6 (device codes): imdrf device code a051201 captures the reportable event of tube dislodged or dislocated.

Event Description

It was reported to boston scientific corporation that an endovive one step button pull method was used during a gastrostomy placement procedure performed on (b)(6) 2023.During the procedure, when the device was being pulled through the abdominal wall out of the body, the button became dislodged.The procedure was completed with a new endovive one step button pull method.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6 (device codes): imdrf device code a051201 captures the reportable event of tube dislodged or dislocated.Block h10: the returned endovive one step button pull method was analyzed.Upon visual assessment, the delivery system (feeding - button dome - pull wire) did not present any visual damage or abnormalities.Therefore, the reported complaint cannot be confirmed.Based on the condition of the returned device, engineers determined the reported event feeding tube - dislodged or dislocated 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.

Event Description

It was reported to boston scientific corporation that an endovive one step button pull method was used during a gastrostomy placement procedure performed on (b)(6) 2023.During the procedure, when the device was being pulled through the abdominal wall out of the body, the button became dislodged.The procedure was completed with a new endovive one step button pull method.There were no patient complications reported as a result of this event.

• Brand Name: ENDOVIVE OSB KIT PULL W/ENFIT 24F 3.4CM
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 16795828
• MDR Text Key: 313827993
• Report Number: 3005099803-2023-02173
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K161003
• 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: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509670
• Device Catalogue Number: 57741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• 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