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

Model Number M00566470

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

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 stated that the device was used prior to the expiration date.(b)(4) relates to component code (b)(4) for the reported event of peg tube difficulty placing/retracting.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 peg kit push method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, they encountered resistance when they tried pulling the peg tube through the stoma site.As they continued to pull it, the catheter elongated.They still continued to pull it and the tip of the tubing stretched and elongated, only the tip elongated as the 2/3 way down part of the tube got back to its normal lumen size.They were able to pull the tube through the patient's stoma site and placed it successfully.Reportedly, the patient may have had a surgical mesh that they were trying to pull the peg through.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

Correction: age.Patient's exact age is unknown; however it was reported that the patient was over the age of 18.

Event Description

It was reported to boston scientific corporation that an endovive safety peg kit push method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, they encountered resistance when they tried pulling the peg tube through the stoma site.As they continued to pull it, the catheter elongated.They still continued to pull it and the tip of the tubing stretched and elongated, only the tip elongated as the 2/3 way down part of the tube got back to its normal lumen size.They were able to pull the tube through the patient's stoma site and placed it successfully.Reportedly, the patient may have had a surgical mesh that they were trying to pull the peg through.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.

• 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: 5866437
• MDR Text Key: 51872282
• Report Number: 3005099803-2016-02341
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

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: M00566470
• Device Catalogue Number: 6647
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/10/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• 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