MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ENDOVIVE¿ SECURI-T¿; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number M00568151

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

The exact event date is unknown; however, it was reported that the event occurred in (b)(6) 2016.(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

It was reported to boston scientific corporation that a securi-t percutaneous replacement gastrostomy tube was used during a gastrostomy replacement procedure performed in (b)(6) 2015.According to the complainant, during the procedure to replace the device in (b)(6) 2016, they noted that the distal portion of the internal bolster was buried in the stomach wall.Resistance was met during withdrawal, the internal bolster detached and remained inside the stomach.They used forceps to remove the detached part from the patient.They found that the tube was bent/kinked between the internal bolster and the tube.The procedure was completed with a new securi-t percutaneous replacement gastrostomy 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 good.

Manufacturer Narrative

A visual examination revealed the presence of heavy dark residue inside the device, indicating use/handling.The feeding port, medicine port and the c-clamp were closed.The external bolster was located at the 3cm mark and was without issue.The internal bolster was found to be separated from the device.Remnants of the bolster remained on the tubing end.It appeared that the internal bolster had been securely molded to the tubing.The tubing did not present evidence of material degradation during implantation.The complaint was consistent with the reported event of bolster detached/separated.The bolster failure appeared to have occurred while undergoing shear force during the removal of feeding tube from the patient.Therefore, the most probable root cause of 'operational context' is selected for the complaint.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation that a securi-t percutaneous replacement gastrostomy tube was used during a gastrostomy replacement procedure performed in (b)(6) 2015.According to the complainant, during the procedure to replace the device in (b)(6) 2016, they noted that the distal portion of the internal bolster was buried in the stomach wall.Resistance was met during withdrawal, the internal bolster detached and remained inside the stomach.They used forceps to remove the detached part from the patient.They found that the tube was bent/kinked between the internal bolster and the tube.The procedure was completed with a new securi-t percutaneous replacement gastrostomy 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 good.

• Brand Name: ENDOVIVE¿ SECURI-T¿
• 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: 5399445
• MDR Text Key: 37144855
• Report Number: 3005099803-2016-00109
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K961345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: M00568151
• Device Catalogue Number: 6815
• Device Lot Number: 17809774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2016
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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 Outcome(s): Required Intervention