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

Model Number M00509030

Device Problems 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 04/04/2023

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit push method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure on (b)(6) 2023.It was reported that, during device placement, the peg tube broke off.The detached portion was surgically retrieved.The procedure was completed with a new endovive standard peg kit push method.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.Block h6 (impact codes): impact code f19 captures the reportable event of surgical intervention.Impact code f23 captures the reportable event of unexpected medical intervention.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit push method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure on (b)(6) 2023.It was reported that, during device placement, the peg tube broke off.The detached portion was surgically retrieved.The procedure was completed with a new endovive standard peg kit push method.There were no reported patient complications as a result of this event.

Manufacturer Narrative

Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.Block h6 (impact codes): impact code f19 captures the reportable event of surgical intervention.Impact code f23 captures the reportable event of unexpected medical intervention.Block h10: an introducer dilator tube detached from the endovive safety peg kit push method was returned for analysis.Visual analysis of the device revealed that the peg tube separated from the introducer dilator at the joint between the parts, with evidence of tooling damage at the location of the separation.In addition, a visual inspection of the guidewire was conducted and found kinks along the length of the guidewire.Therefore, the reported complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to user technique/handling, patient anatomy, and the size of the incision site that the tube was being pulled through, contributed to the reported tubing detachment.Boston scientific has determined the most probable cause of this complaint is known inherent risk of device.It is most likely that the adverse event occurred during the procedure and the device are known and documented in the labeling.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu)/product label.

• 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; 500 commander shea boulevard; quincy MA 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16831990
• MDR Text Key: 314177339
• Report Number: 3005099803-2023-02217
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 08714729880448
• UDI-Public: 08714729880448
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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 Expiration Date: 04/30/2023
• Device Model Number: M00509030
• Device Catalogue Number: 57707
• Device Lot Number: 0029076286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/28/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• 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