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

Model Number M00509081

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure on (b)(6) 2022.During the procedure, the internal bolster exits to the stomach wall thus making the peg tube less stable.The procedure was completed was completed with a new endovive standard peg kit pull method.There were no reported patient complications as a result of this event.

Manufacturer Narrative

(b)(4).(evaluation conclusion codes): the device has not been received for analysis.Upon receipt and 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.

• Brand Name: ENDOVIVE STANDARD 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: 13414103
• MDR Text Key: 287267660
• Report Number: 3005099803-2022-00439
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): Y
• Reporter Country Code: IT
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509081
• Device Catalogue Number: 57706
• Device Lot Number: 0028052607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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