Model Number VEL160STR-A |
Device Problems
Crack (1135); Split (2537)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Results: the first velocity delivery microcatheter (velocity) evaluated was fractured approximately 8.0 cm from the hub.Conclusions: evaluation of the returned devices revealed the first and second velocity devices were fractured in their proximal shafts.This damage may have occurred due to forceful retraction of the velocity devices against resistance.Further evaluation revealed the second velocity was kinked and bent.This damage may have occurred due to forceful advancement of the velocity against resistance during use.The third velocity returned for evaluation was inside its unopened sterile pouch, and had no visible damage.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.This report is associated with mfr report number: 3005168196-2017-00090.
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Event Description
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During preparation for a thrombectomy procedure, the physician noticed that the distal end of two velocity delivery microcatheters (velocities) became cracked and split upon removal from the hoop retainers.The damage to the velocities were noticed prior to use and therefore, they were not used in the procedure.The procedure was completed using a non-penumbra catheter.
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Event Description
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The patient was undergoing a thrombectomy procedure using velocity delivery microcatheters (velocity).During the procedure, the physician noticed that the distal end of two velocity delivery microcatheters (velocities) became cracked and split; therefore they were removed.The procedure was completed using a non-penumbra catheter.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2017-00089.This report is associated with mfr report number: 3005168196-2017-00090.
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Search Alerts/Recalls
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