MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. ENDOVIVE SAFETY PEG KIT, 20 FRENCH, "PULL" PERCUTANEOUS ENDOSCOPIC GASTROSTOMY K; TUBES, GASTROINTESTINAL

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 12/21/2018

Event Type  Injury  

Event Description

During patient care, it was discovered the patient's peg tube had become dislodged and was laying in the bed.Balloon bulb was noted to be in correct place in stomach via egd.

• Brand Name: ENDOVIVE SAFETY PEG KIT, 20 FRENCH, "PULL" PERCUTANEOUS ENDOSCOPIC GASTROSTOMY K
• Type of Device: TUBES, GASTROINTESTINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 8239517
• MDR Text Key: 133244784
• Report Number: MW5083055
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR