KANEKA CORPORATION METACROSS RX PTA BALLOON DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL,
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Catalog Number BD-L70060CR |
Device Problems
Use of Device Problem (1670); Device Handling Problem (3265)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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The concerned device "metacross rx" is a rapid exchange (rx) type pta balloon dilatation catheter compatible to 0.035" guidewire (gw)."metacross rx" is distributed in the us under 510(k) # k150865.The device history records (dhr - batch record) of the concerned device was reviewed and no nonconformity or abnormality in the manufacturing processes was found.The concerned device, metacross rx, was returned together with the sheath and gw used, and was investigated: the balloon was stuck on the sheath tip.When the balloon was carefully removed from the sheath, the balloon was wrinkled toward the tip side.There was no evidence of balloon destruction.The catheter was broken at 1140mm from the tip.It was confirmed that all balloon catheters were collected.The total length of the broken balloon catheter was about 1705 mm and was extended about 350 mm.(product standard is 1350mm) deformation was seen at the sheath tip.Probable cause and comments: we speculate the reported situation as follows: the frictional resistance between the balloon and the sheath tip increased due to the inflow of blood, and the shaft stuck, and the shaft broke due to excessive pulling force.No nonconformity or abnormality was found in the manufacturing processes according to the dhr.We believe the reported problem would not be caused by any defect of the device.
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Event Description
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The customer used a metacross rx 7x60 transbrachial over a 6fr destination 90cm.After dilatation, the deflated balloon should be removed from the vessel.The balloon did not go well through the sheath and was finally demolished.A piece of the balloon got stuck at the end of the sheath.The sheath with the balloon rest was recovered to the elbow and the rest was then recovered surgically.There are no parts of the product left in the patient.In addition to the intervention, a surgical procedure had to be performed in order to be able to remove the rest of the balloon as described above.
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Search Alerts/Recalls
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