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

Model Number M00509000

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/21/2023

Event Type  malfunction  

Event Description

During placement of the peg tube, the peg guidewire became detached.The physician ended up applying his hand over the wire part to protect the patient.The physicians was able to complete the placement.No untoward patient effects.The patient was taken to recovery in stable condition.

• 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
• MDR Report Key: 16643030
• MDR Text Key: 312340345
• Report Number: 16643030
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 08714729880387
• UDI-Public: (01)08714729880387
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509000
• Device Lot Number: 30521126
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Sex: Male
• Patient Ethnicity: Hispanic