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

Model Number M00568211

Device Problems Occlusion Within Device (1423); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that an endovive standard peg kit push method was used during an esophagogastroduodenoscopy with percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2014.According to the complainant, during the procedure, when the physician was tracking the peg tube over the guidewire, it was met with resistance.It was reported that the guidewire would not advance at the transition zone between the hard and soft plastic.The procedure was not completed due to this event; however, it was stated the physician intends to perform another procedure to place a new peg tube.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

(b)(4).The complainant indicated that the device was disposed and 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? STANDARD 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3635255
• MDR Text Key: 3987203
• Report Number: 3005099803-2014-00845
• 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: 01/28/2014

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 Expiration Date: 07/31/2015
• Device Model Number: M00568211
• Device Catalogue Number: 6821
• Device Lot Number: 16286141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 02/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2013
• 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