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

Model Number M00509000

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

Event Date 06/04/2023

Event Type  malfunction  

Event Description

Facility has switched to boston scientific endovive pull pegs from avanos pull pegs.The wire is weak in the endovive kit and breaks when attempting to pull the trocar through.The wire broke twice in the past, and today partially broke.If the wire breaks before the trocar exits the skin, it will result in an open gastric perforation.

• Brand Name: ENDOVIVE SAFETY PEG KIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 17583547
• MDR Text Key: 321533458
• Report Number: 17583547
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2023,06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M00509000
• Device Catalogue Number: M00509000
• Device Lot Number: 31275119
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Sex: Female