Model Number M001145150 |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 05/29/2015 |
Event Type
Injury
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Event Description
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It was reported that shaft break, catheter removal difficulty and vessel perforation occurred.The target lesion was located in the superior vena cava.A 7fr sheath was placed and a 14-4/5.8/120 xxl¿ vascular balloon catheter was used.After the procedure, an attempt was made to remove the balloon catheter however the shaft of the catheter split and came off, leaving a segment of the balloon and the tip of the shaft on the guide wire inside the patient.A snare was placed over the wire tip and an attempt was done to pull the balloon back through the sheath but this was unsuccessful as the balloon had formed a "ball." both the sheath and the balloon "ball" were removed together.It was then noted that there was a large hole in the vessel which responded to manual compression.The procedure was completed.No further patient complications were reported and the patient's status was stable.
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Manufacturer Narrative
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(b)(4).
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Manufacturer Narrative
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Device evaluated by mfr: the device was received in two sections along with a guide wire.A break in the shaft and a complete balloon circumferential tear was evident with the returned device.The circumferential tear in the balloon was located approximately 1cm distal to the proximal markerband.The distal section of the balloon tear was completely bunched up towards the tip.This section of balloon material was unraveled and examined.No other tears or damage was noted with this section of the balloon material.A break was present in the shaft at 1cm distal to the proximal markerband.An examination of the break site found that the shaft was stretched.This type of damage is consistent with excessive tensile force having been applied to the shaft.Approximately 3cm distal from the break site an impression was noted on the shaft, consistent with a clamp or forceps having been applied to the shaft.An examination of the guide wire identified no anomalies.The outer diameter of the guide wire was measured to be within specification for use with this device.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factor.(b)(4).
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Event Description
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It was reported that shaft break, catheter removal difficulty and vessel perforation occurred.The target lesion was located in the superior vena cava.A 7fr sheath was placed and a 14-4/5.8/120 xxl¿ vascular balloon catheter was used.After the procedure, an attempt was made to remove the balloon catheter however the shaft of the catheter split and came off, leaving a segment of the balloon and the tip of the shaft on the guide wire inside the patient.A snare was placed over the wire tip and an attempt was done to pull the balloon back through the sheath but this was unsuccessful as the balloon had formed a "ball." both the sheath and the balloon "ball" were removed together.It was then noted that there was a large hole in the vessel which responded to manual compression.The procedure was completed.No further patient complications were reported and the patient's status was stable.
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Search Alerts/Recalls
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