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 01/15/2014

Event Type  malfunction  

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-00685 and 3005099803-2014-00686 for the other associated device information.It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy procedure 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 there was an obstruction noted at the transition zone between the hard and soft plastic.A second endovive safety peg kit push method was opened, however, the same issue occured.The procedure was completed with a third endovive safety peg kit push method.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 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 the device to be without issue.A functional evaluation was performed by attempting to pass a.035" guidewire through the delivery system.The guidewire would not pass through the barbed connector from either direction.The device was disassembled by cutting off the outer ring and then removing the thermoformed tubing and silicone tubing from the barbed connector.The barbed connector was pin gauged and it was found to be partially occluded.The inner diameter would only accept a.020" pin gauge, however the specification is.036" to.040".A microscopic examination of the id of the barbed connector cannula revealed that adhesive was visible on the end of the threaded end of the connector and partially occluding the inner diameter of the connector.It was noted that the condition of the returned unit was consistent with the complaint incident that a.035" guidewire would not pass through the connector.Adhesive is placed on the barbed connector during the manufacturing assembly process, therefore the most probable root cause of 'manufacturing' is selected for the complaint.There is an investigation in place to address this issue.A review of the device history record was performed for lot number 16286141 and revealed no issues related to this complaint.

Event Description

Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2014-00685 and 3005099803-2014-00686 for the other associated device information.It was reported to boston scientific corporation that an endovive safety peg kit push method was used during a percutaneous endoscopic gastrostomy procedure 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 there was an obstruction noted at the transition zone between the hard and soft plastic.A second endovive safety peg kit push method was opened, however, the same issue occured.The procedure was completed with a third endovive safety peg kit push method.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.

• 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: 3607445
• MDR Text Key: 4160967
• Report Number: 3005099803-2014-00686
• 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,Followup
• Report Date: 01/16/2014

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 02/05/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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