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

Model Number M00566480

Device Problems Entrapment of Device (1212); Migration or Expulsion of Device (1395)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The patient's weight is (b)(6).The complainant indicated that the device will not be returned for evaluation as it is implanted in the patient; 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 kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2015.According to the complainant, the patient had bloody/pus like discharge and infection at the stoma site.A prescription antibiotic was prescribed for the infection (exact name is unknown.) on (b)(6) 2016 a replacement of the peg tube was done and it was noted the tube had buried bumper syndrome.There were no patient complications reported as a result of this event.The patient's condition was reported to be normal.

Event Description

It was reported to boston scientific corporation that an endovive safety kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2015.According to the complainant, the patient had bloody/pus like discharge and infection at the stoma site.A prescription antibiotic was prescribed for the infection (exact name is unknown).On (b)(6) 2016 a replacement of the peg tube was done and it was noted the tube had buried bumper syndrome.There were no patient complications reported as a result of this event.The patient's condition was reported to be normal.

Event Description

It was reported to boston scientific corporation that an endovive safety kit pull method was used during a percutaneous endoscopic gastrostomy procedure performed on (b)(6) 2015.According to the complainant, the patient had bloody/pus like discharge and infection at the stoma site.A prescription antibiotic was prescribed for the infection (exact name is unknown.) on (b)(6) 2016 a replacement of the peg tube was done and it was noted the tube had buried bumper syndrome.There were no patient complications reported as a result of this event.The patient's condition was reported to be normal.***additional information as of june 15, 2016.*** the replacement of the peg tube on (b)(6) 2016 was a routine replacement.On (b)(6) 2016, the patient had buried bumper syndrome and on (b)(6) 2016, the patient had a stoma site infection.Reportedly, no treatment was given for the infection.On (b)(6) 2016 the peg tube was replaced (manufacturer of device unknown).

• 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: 5493685
• MDR Text Key: 40113270
• Report Number: 3005099803-2016-00553
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: SE
• PMA/PMN Number: K031538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2016

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: 09/30/2017
• Device Model Number: M00566480
• Device Catalogue Number: 6648
• Device Lot Number: 18718246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/08/2016; 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• 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