MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE SAFETY PEG KIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number M00509181

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/26/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6 (device codes): imdrf device code a0501 captures the reportable event of internal bolster detached.Block h10: the returned endovive safety peg kit was analyzed.During visual inspection, it was observed that all the components of the kit were returned.Therefore, the reported event of missing component has determined to be no problem detected.However, in addition to the standard components in this kit it was noted there was a detached bolster from a securi-t device.Bolster marks were present that indicate it had been previously attached to the securi-t.Based on the condition of the returned device, engineers determined that the reported complaint cannot be substantiated or confirmed.It is likely that the detachment of the bolster occurred either during handling or storage of the device.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 safety peg kit pull was used during a percutaneous endoscopic gastrostomy tube replacement on (b)(6), 2023.During procedure, when the kit was opened, it was found that the contents were insufficient.Hence, were not used at all.The procedure was completed with a different device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of a detached bolster from a securi-t device which was found in this return kit as well.As indicated by visible marks suggesting a previous attachment.Please see block h10 for full investigation details.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• 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: 17414462
• MDR Text Key: 320397727
• Report Number: 3005099803-2023-04043
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K150679
• 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
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509181
• Device Catalogue Number: 57708
• Device Lot Number: 0031361758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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