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

Model Number M00566720

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2015

Event Type  Injury  

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, the peg tube was difficult to pull through the stoma site.The physician decided to make a larger incision to accommodate the peg tube.Reportedly, the incision size was of proper size initially.The procedure was completed with this endovive safety peg kit pull method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over 18 years old.The reported lot number could not be matched to the reported device.Therefore, the lot expiration and device manufacture dates are unknown at this time.However, the complainant reported that the device was not expired.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

Additional information: the device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, 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, the peg tube was difficult to pull through the stoma site.The physician decided to make a larger incision to accommodate the peg tube.Reportedly, the incision size was of proper size initially.The procedure was completed with this endovive safety peg kit pull method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Additional information received on april 13, 2015: the physician was concerned that there was a small ridge where the peg tube is connected to the plastic dilator.The physician felt that the incision size was fine.

Manufacturer Narrative

A visual examination of the returned device revealed that it had been cut at approximately 6.8 cm from the outer ring.The wire loop at the end of the dilating tip had been cut off adjacent to the tip.Several cuts were found on the surface of the outer ring, continuing through the tubing and into the dilating tip.The device did not present any unusual ridges in the transition area.The distal portion of the feeding tube including the bolster, was not returned.It was noted that the condition of the returned device could not be functionally evaluated with respect to feeding tube difficulty placing during the procedure.Based on all gathered information, the most probable root cause is "operational context.".

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, the peg tube was difficult to pull through the stoma site.The physician decided to make a larger incision to accommodate the peg tube.Reportedly, the incision size was of proper size initially.The procedure was completed with this endovive safety peg kit pull method.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.Additional information received on april 13, 2015: the physician was concerned that there was a small ridge where the peg tube is connected to the plastic dilator.The physician felt that the incision size was fine.

• 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: 4680647
• MDR Text Key: 5636864
• Report Number: 3005099803-2015-01035
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 03/30/2015

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 Model Number: M00566720
• Device Catalogue Number: 6672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/27/2015; 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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