MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC ENDOVIVE STANDARD PEG KIT

Model Number 0871472980462

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Peritonitis (2252); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/18/2021

Event Type  Death  

Event Description

We are filing this report not because we are convinced that the peg tube did not function as designed, but based entirely on adverse outcome for this patient.Patient had a bs peg tube placed in the operating room on (b)(6) 2021.This patient had a peg 1 year earlier after being injured in (b)(6).Patient required 1:1 sitter to prevent tube/iv manual removal by patient who was confused.Patient also transported to cat scan and later to medical unit from the icu.Proper placement of tube confirmed on (b)(6) 2021 via cat scan.Patient later developed symptoms of an acute abdomen.Upon return to operating room, peg found to have dis­lodged from stomach, resulting in peritonitis.Patient later expired.The peg involved was not retained, but there was no report from the or team who removed the peg that there were any defects or missing parts upon extraction.We are not reporting this as a product detect, as we have no evidence of any product defect, but are reporting based entirely on the adverse outcome.The investigation by the hospital concluded that the tube was more likely than not to have been manually dislodged: either by the confused patient, or during patient transport/repositioning.

Event Description

We are filing this report not because we are convinced that the peg tube did not function as designed, but based entirely on adverse outcome for this patient.Patient had a bs peg tube placed in the operating room on (b)(6) 2021.This patient had a peg 1 year earlier after being injured in (b)(6).Patient required 1:1 sitter to prevent tube/iv manual removal by patient who was confused.Patient also transported to cat scan and later to medical unit from the icu.Proper placement of tube confirmed on (b)(6) 2021 via cat scan.Patient later developed symptoms of an acute abdomen.Upon return to operating room, peg found to have dis­lodged from stomach, resulting in peritonitis.Patient later expired.The peg involved was not retained, but there was no report from the operating room team who removed the peg that there were any defects or missing parts upon extraction.We are not reporting this as a product detect, as we have no evidence of any product defect, but are reporting based entirely on the adverse outcome.The investigation by the hospital concluded that the tube was more likely than not to have been manually dislodged: either by the confused patient, or during patient transport/repositioning.

• Brand Name: BOSTON SCIENTIFIC ENDOVIVE STANDARD PEG KIT
• Type of Device: BOSTON SCIENTIFIC ENDOVIVE STANDARD PEG KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 13549349
• MDR Text Key: 285980708
• Report Number: 13549349
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: 0871472980462
• Device Catalogue Number: M00509040
• Device Lot Number: 27220297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/13/2022
• Distributor Facility Aware Date: 12/20/2021
• Device Age: 1 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 135 KG