MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SECURI-T; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00509161

Device Problems Detachment of Device or Device Component (2907); Human-Device Interface Problem (2949)

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

Event Date 01/06/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a replacement gastrostomy procedure on (b)(6) 2022.Reportedly, when the caregiver was cleaning the securi-t, the device dislodged outside the patient and the internal bolster detached inside the patient.The patient went to the hospital and the bolster was retrieved through a net with the endoscope.The procedure was completed with another endovive securi-t device.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): device code a0501 captures the reportable event of internal bolster detached.Device code a22 captures the reportable event of patient removal.Block h10: an endovive securi-t percutaneous replacement bolster was returned.Visual analysis of the device revealed that the internal bolster detached from the tube and traces of adhesion in the distal end of the tube.In addition, the inner ring mark on the bolster presumes that it was attached.Media inspection showed the internal bolster detached and has remnants of use.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to the manipulation or anatomical conditions of the patient could have contributed to the separation.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.It is most likely that the adverse event occurred during the procedure and the device had no influence on event which led to the reported event.

Event Description

It was reported to boston scientific corporation that an endovive securi-t replacement bolster was used during a replacement gastrostomy procedure on (b)(6) 2022.Reportedly, when the caregiver was changing the patients clothes, the clothing got caught on the device, and the internal bolster detached inside the patient.The patient went to the hospital and the bolster was retrieved through a net with the endoscope.The procedure was completed with another endovive securi-t device.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: 16246657
• MDR Text Key: 308169750
• Report Number: 3005099803-2023-00190
• 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: 02/28/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA Received: 01/26/2023
• Supplement Dates Manufacturer Received: 02/08/2023
• Supplement Dates FDA Received: 02/28/2023
• 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
• Patient Outcome(s): Other
• Patient Sex: Female