MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ENDOVIVE STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568211

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

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

Event Date 07/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit push method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure on (b)(6) 2021.On (b)(6) 2021, the peg tube was leaking enteral feeding nutrition formula and when flushed it leaked from the site.A ct scan was performed and it was noted that the peg tube was dislodged with the bolster in the subcutaneous soft tissues and outside the lumen of the stomach.On (b)(6) 2021, it was replaced with a non-boston scientific peg tube.It was reported that patient was given iv antibiotics for five days to prevent any abdominal wall infection.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 12775193
• MDR Text Key: 284981910
• Report Number: 3005099803-2021-05806
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729285205
• UDI-Public: 08714729285205
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2022
• Device Model Number: M00568211
• Device Catalogue Number: 6821
• Device Lot Number: 0027093302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 101 KG