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

Model Number M00568201

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Perforation (2001)

Event Date 04/20/2023

Event Type  Injury  

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 on (b)(6) 2023.It was reported that, during device placement, the peg tube fractured and left an open track into the peritoneal space.No pieces of the device were left inside the patient.The patient was sent for surgery.It was reported the patient is expected to fully recover.

Manufacturer Narrative

Block h6 (device codes): imdrf device code a0501 captures the reportable event of peg tube detached.Block h6 (impact codes): impact code f19 captures the reportable event of surgical intervention.Block h10: the returned endovive standard peg kit pull method was analyzed.Upon visual assessment, it was observed that the peg tube separated from the retrieval loop at the joint between the parts.Therefore, the complaint is confirmed.Based on the condition of the returned device, engineers determined that the problem observed could be related to the operational factors, such as user technique/handling, patient anatomy, and the size of the incision site that the tube was being pulled through could have contributed to the reported tubing detachment.Boston scientific has determined the most probable cause of this complaint is known inherent risk of device.It is most likely that the adverse event occurred during the procedure and the device had no influence on the event which led to the reported event.

• 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: 16938944
• MDR Text Key: 315295411
• Report Number: 3005099803-2023-02504
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 08714729285199
• UDI-Public: 08714729285199
• 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: Physician
• Type of Report: Initial
• Report Date: 05/16/2023

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: M00568201
• Device Catalogue Number: 6820
• Device Lot Number: 0031356548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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
• Patient Age: 69 YR
• Patient Sex: Female