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

Model Number M00566460

Device Problems Break (1069); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2014

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 (egd) with percutaneous endoscopic gastrostomy placement procedure performed on (b)(6) 2014.According to the complainant, during the procedure, the physician felt resistance while pulling the peg tube through the stomach.It was reported that the loop at the end of the peg tube broke outside the patient.The physician continued pulling the peg tube and completed the procedure with this device.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 doing well.

Manufacturer Narrative

Reported event of loop wire at the end of peg tube broke.Reported event of difficulty placing the tube.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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3645827
• MDR Text Key: 15269629
• Report Number: 3005099803-2014-01151
• 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: 02/04/2014

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: 08/31/2015
• Device Model Number: M00566460
• Device Catalogue Number: 6646
• Device Lot Number: 16656717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2014
• 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 Age: 90 YR