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

Model Number M00568380

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit pull method was used during a percutaneous endoscopic gastrostomy (peg) placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, when the physician was pulling the peg tube through the stoma, the bolster came out the incision site.Reportedly the physician, stated the internal bolster was too small.In addition, the incision size was unknown.It was also stated the physician does not usually make a cut beforehand, only if he is having trouble pulling the feeding tube through the hole, which was made.The procedure was completed with a non-bsc device.There were no patient complications reported as a result of this 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: 8687830
• MDR Text Key: 147623668
• Report Number: 3005099803-2019-02883
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: M00568380
• Device Catalogue Number: 6838S
• Device Lot Number: 0020794396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2017
• 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