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); Device Dislodged or Dislocated (2923)

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

Event Date 11/20/2021

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an endovive securi-t percutaneous replacement gastrostomy tube was used during a gastrostomy replacement procedure performed on (b)(6) 2021.During procedure, the internal bolster detached from the tube and dislodged inside the stomach.It was reported that the dislodged internal bolster was retrieved using endoscope.The procedure was completed with a new endovive securi-t percutaneous replacement gastrostomy tube.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6 (device codes): device problem code a0501 captures the reportable event of internal bolster detached.Device problem code a051201 captures the reportable event of internal bolster dislodged or dislocated.Block h6 (evaluation conclusion codes): the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endovive securi-t percutaneous replacement gastrostomy tube was used during a gastrostomy replacement procedure performed on (b)(6) 2021.During procedure, the internal bolster detached from the tube and dislodged inside the stomach.It was reported that the dislodged internal bolster was retrieved using endoscope.The procedure was completed with a new endovive securi-t percutaneous replacement gastrostomy tube.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Correction: h6 (impact codes).Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6 (device codes): device problem code a0501 captures the reportable event of internal bolster detached.Device problem code a051201 captures the reportable event of internal bolster dislodged or dislocated.Block h6 (impact codes).Impact code f23 captures the reportable event of unexpected medical intervention.Block h6 (evaluation conclusion codes): the device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endovive securi-t percutaneous replacement gastrostomy tube was used during a gastrostomy replacement procedure performed on (b)(6) 2021.During procedure, the internal bolster detached from the tube and dislodged inside the stomach.It was reported that the dislodged internal bolster was retrieved using endoscope.The procedure was completed with a new endovive securi-t percutaneous replacement gastrostomy tube.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6 (device codes): device problem code a0501 captures the reportable event of internal bolster detached.Device problem code a051201 captures the reportable event of internal bolster dislodged or dislocated.Block h6 (impact codes) impact code f23 captures the reportable event of unexpected medical intervention.Block h10: an endovive securi-t replacement bolster was returned.Visual analysis revealed that the internal bolster was detached.Microscope inspection determined that the bolster was attached once.Media inspection confirmed the reported issue.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 technique/manipulation applied when the physician was inserting the tube and internal bolster inside the patient as consequence the bolster could got dislodged inside the patient.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.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed on the endovive securi-t replacement bolster instructions for use (ifu).There was no evidence that the device was used in a manner inconsistent with the labeled indications.

Event Description

It was reported to boston scientific corporation that an endovive securi-t percutaneous replacement gastrostomy tube was used during a gastrostomy replacement procedure performed on (b)(6) 2021.During procedure, the internal bolster detached from the tube and dislodged inside the stomach.It was reported that the dislodged internal bolster was retrieved using endoscope.The procedure was completed with a new endovive securi-t percutaneous replacement gastrostomy tube.There were no reported patient complications 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: 13098285
• MDR Text Key: 284444637
• Report Number: 3005099803-2021-07981
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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
• Device Lot Number: 0027764923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2021
• 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