Model Number 112264-002 |
Device Problem
Hole In Material (1293)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the catheter was punctured.A 2.1mm jetstream® xc atherectomy catheter was selected for an atherectomy procedure in the superficial femoral artery(sfa).During the procedure, the jetstream was used in the proximal sfa.The operator removed the catheter from the sheath due to a stiff feeling; the catheter could not be forwarded through the 7f sheath.They attempted to prime the catheter again, but the distal part of the catheter inflated during flushing.The coated surface of the catheter was punctured.There were no patient complications reported and the patient's status was reported as good.The procedure was completed with a different device.
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Manufacturer Narrative
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Device evaluated by mfr: returned product consisted of a jetstream xc-2.1 atherectomy catheter in one piece.The shaft and the remainder of the device were checked for damage.It was noticed that the shaft had buckling approximately 4cm from the tip.There was also a burst outer sheath approximately 6 to 7cm from the tip.When the inner sheath gets kinked damaged or buckled it restricts the fluid flow proximal of where the damage occurred.When the fluid is restricted it causes the outer sheath to swell and burst as it did in this case.Functional testing was done by completing the set up procedure and the device functioned; however, leaked at the burst point of the outer sheath.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 factors.(b)(4).
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Event Description
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It was reported that the catheter was punctured.A 2.1mm jetstream® xc atherectomy catheter was selected for an athrectomy procedure in the superficial femoral artery(sfa).During the procedure, the jetstream was used in the proximal sfa.The operator removed the catheter from the sheath due to a stiff feeling; the catheter could not be forwarded through the 7f sheath.They attempted to prime the catheter again, but the distal part of the catheter inflated during flushing.The coated surface of the catheter was punctured.There were no patient complications reported and the patient's status was reported as good.The procedure was completed with a different device.
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Search Alerts/Recalls
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