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

Model Number M00566460

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit pull method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure.Procedure date is unknown.According to the complainant, during the procedure, the peg tube got stuck while it was pulled through the abdomen.The peg tube was not easily sliding through the stoma and a lot of force had to be used to pull it out.The physician felt that the dilating tip was not smooth and there was a slight ridge that got stuck on the abdominal wall.Reportedly, the incision size is appropriate (exact size unknown.) the procedure was completed with this endovive safety peg kit pull method.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.Reported event of peg tube difficulty placing/retracting.The complainant indicated that the device will not be returned for evaluation; 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.

• 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: 4860340
• MDR Text Key: 5812632
• Report Number: 3005099803-2015-01589
• 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
• Report Date: 05/28/2015

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: Physician
• Device Model Number: M00566460
• Device Catalogue Number: 6646
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2015
• Initial Date FDA Received: 06/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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