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Model Number 5MAXJETDKIT |
Device Problems
Fluid/Blood Leak (1250); Material Deformation (2976)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Results: the jetd was kinked distal to the strain relief approximately 3.5 cm from the hub.Conclusions: evaluation of the returned jetd confirmed a kink but could not confirm the reported leak.If the device is manipulated at extreme angles during use, damage such as a kink may occur.During functional testing, the jetd was flushed with air while submerged in the bleach solution, but no air was observed from the kink.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
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Event Description
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The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jetd reperfusion catheter (jetd).During the procedure, the physician made one pass in the target vessel and subsequently removed the jetd.While examining the jetd on the back table, the hospital technologist noticed a kink on the proximal end of the jetd.However, upon flushing the jetd, the jetd was still intact.The physician continued with the procedure using the same jetd and made two additional passes.Subsequently, the physician removed the jetd.After flushing the jetd on the back table again, the jetd was leaking saline at the kinked portion.Therefore, the jetd was not used for the remainder of the procedure.The procedure was completed using a new jetd, resulting in a thrombolysis in cerebral infarction (tici) grade 3 recanalization.There was no report of an adverse effect to the patient.
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Search Alerts/Recalls
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