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 11/01/2022

Event Type  malfunction  

Manufacturer Narrative

(date of event): date of event was approximated to (b)(6) 2022 as no event date was reported.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.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 securi-t replacement bolster was used.The procedure date was unknown.The bumper that had been implanted for about two months had fallen off and could no longer be used continuously.The procedure was completed with another endovive securi-t 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.The procedure date was unknown.The bumper that had been implanted for about two months had fallen off and could no longer be used continuously.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 b3 (date of event): date of event was approximated to 11/01/2022 as no event date was reported.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 e1: the complainant was unable to provide physician information, the reported healthcare facility is: (b)(6) hospital.Block h6 (device codes): device code a0501captures the reportable event of internal bolster detached.The returned endovive securi-t replacement bolster was analyzed.Upon visual assessment, it was observed that silicone tube of the bolster was detached.There are adhesion traces that presumes that it was attached.The bolster did not return.Therefore, the complaint is confirmed.Based on the condition of the returned device, engineers determined that based upon the adhesion traces found in the silicone tube suggest that the bolster was detached due to an excess of tension.As it was reported the device was implanted for at least 2 months, perhaps during that time the manipulation, or the patient's anatomical conditions could have contributed to this event.Boston scientific has determined the most probable cause of this complaint is adverse event related to procedure.

• 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: 16045238
• MDR Text Key: 308388891
• Report Number: 3005099803-2022-07637
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M00509161
• Device Catalogue Number: 0916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2023
• 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