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

Model Number M00568151

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a securi-t percutaneous replacement gastrostomy tube was used during a replacement procedure performed on (b)(6) 2013.According to the complainant, during the withdrawal of the device, it was noted that a part of the tube (at around 2.5cm from the bolster) was deformed.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

The patient¿s exact age is unknown, however, it was reported that the patient was over 18 years old.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

A visual examination of the device revealed that the external bolster was located at the 5 cm mark and was without issue.An examination of the feeding tube surface present a slight degradation around the circumference near the 2.5 cm mark.The ink markings on the surface were worn proximal to the 3 cm mark, most likely from cleaning the external surface of the tubing.If the bolster was covering the 2.5 and 3 cm markings, the distal end of the external bolster would have been located approximately where the degradation occurred.If the interface between the distal end of the external bolster and the tubing was not cleaned thoroughly or the cleaning solution not rinsed off the surfaces, it could cause the damage noted.It was noted by the cis that the condition of the returned unit was consistent with the complaint incident that the tube was expanded.Based on all gathered information, the most probable root cause of "operational context" is selected for the complaint.

Event Description

It was reported to boston scientific corporation that a securi-t percutaneous replacement gastrostomy tube was used during a replacement procedure performed on (b)(6) 2013.According to the complainant, during the withdrawal of the device, it was noted that a part of the tube (at around 2.5cm from the bolster) was deformed.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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3718094
• MDR Text Key: 4250076
• Report Number: 3005099803-2014-01598
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

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 Model Number: M00568151
• Device Catalogue Number: 6815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2014
• Initial Date FDA Received: 04/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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