MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ SAFETY PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00566521

Device Problem Difficult to Advance (2920)

Patient Problems Laceration(s) (1946); Blood Loss (2597)

Event Date 10/20/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant device has been implanted; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2015.According to the complainant, during the procedure resistance was met at the cardiac region of the stomach while pulling the peg tube.The physician was able to pull the device into the stomach and completed the procedure.After the procedure, bleeding was noticed.Endoscopy confirmed that there was laceration measuring 5 to 8 mm in length and about 1cm from the eg junction.Thrombin was sprayed to treat the bleed.The patient's condition at the conclusion of the procedure was reported to be stable after treatment.

• Brand Name: ENDOVIVE¿ SAFETY PEG KIT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5220390
• MDR Text Key: 31014803
• Report Number: 3005099803-2015-03208
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• 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: 10/21/2015

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: Physician
• Device Expiration Date: 04/26/2017
• Device Model Number: M00566521
• Device Catalogue Number: 6652
• Device Lot Number: 16925932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2015
• Initial Date FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2014
• 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): Required Intervention