MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ ONE STEP BUTTON¿; TUBE, GASTRO-ENTEROSTOMY

Model Number M00563040

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2018

Event Type  malfunction  

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.

Event Description

This report pertains to one of two devices used during the same procedure.Refer to manufacturer report# 3005099803-2018-00992 for the first endovive¿ one step button¿ 3005099803-2018-00993 for the second endovive¿ one step button¿.It was reported to boston scientific corporation that an endovive one step button was used during a peg replacement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the physician tried to grasp the peg tube from the stomach to pull it through but the tube kept breaking.A second one step button gastrostomy kit was used; however, it happened again.Reportedly, alligator forceps were used.The procedure was not completed due to this event.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.

• Brand Name: ENDOVIVE¿ ONE STEP BUTTON¿
• Type of Device: TUBE, GASTRO-ENTEROSTOMY
• 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: 7389441
• MDR Text Key: 104413603
• Report Number: 3005099803-2018-00992
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 08714729268833
• UDI-Public: 08714729268833
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910584
• 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
• Report Date: 03/13/2018

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: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: M00563040
• Device Catalogue Number: 6304
• Device Lot Number: 21435158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2017
• 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: 60 YR