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 Consequences Or Impact To Patient (2199)

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 was 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 gets the peg tube stuck.Reportedly, the incision size is appropriate (exact size unknown.) 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 okay.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over 18 years old.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 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.

Manufacturer Narrative

A visual examination of the returned device revealed that it had been cut at approximately 21cm from the outer ring.The wire loop on the end of the dilating tip had been cut off adjacent to the 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 an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure.Procedure date is unknown.According to the complainant, during the procedure, the peg tube was 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 gets the peg tube stuck.Reportedly, the incision size is appropriate (exact size unknown.) 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 okay.

• 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: 4854024
• MDR Text Key: 17212054
• Report Number: 3005099803-2015-01586
• 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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2015
• Initial Date FDA Received: 06/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/04/2015
• 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