BOSTON SCIENTIFIC - SPENCER ENDOVIVE? STANDARD PEG KIT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)
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Model Number M00568211 |
Device Problems
Occlusion Within Device (1423); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/15/2014 |
Event Type
malfunction
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Event Description
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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.
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Manufacturer Narrative
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(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.
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Manufacturer Narrative
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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.012" pin gauge, however the specification is.036" to.040".A microscopic examination of the id of the barbed connector cannula revealed a clear substance to have formed a ring around the inner wall of the cannula.Adhesive was also visible on the end of the threaded end 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.
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Event Description
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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.
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