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

Model Number M00509080

Device Problem Migration (4003)

Patient Problem Perforation (2001)

Event Date 01/11/2023

Event Type  Injury  

Manufacturer Narrative

H6 (device codes): device problem code a010402 captures the reportable event of internal bolster migration.

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2023.During the procedure, it was observed that the internal bolster had migrated and was lodged in the abdomen resulting to pneumoperitoneum.A second placement was not possible at that time, the hole in the stomach wall was closed endoscopically with four clips covered with tazocin and patient was monitored via ct with contrast.A new endovive standard peg kit pull method was placed at a later date.It was reported the physician did not attribute the pneumoperitoneum to the malfunction of the device.It was related to the smoothness of the silicone bolster compared to one they were using before it was more of a learning curve.

• Brand Name: ENDOVIVE STANDARD PEG KIT
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 16744762
• MDR Text Key: 313360696
• Report Number: 3005099803-2023-01952
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K150679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M00509080
• Device Catalogue Number: 57706
• Device Lot Number: 0029449105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2022
• 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 Outcome(s): Other