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Model Number PXSLIMLAN150STR |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2021-01095, 3005168196-2021-01096, 3005168196-2021-01097, 3005168196-2021-01098, 3005168196-2021-01099, 3005168196-2021-01100, 3005168196-2021-01101, 3005168196-2021-01102.
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Event Description
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The patient was undergoing a coil embolization procedure to treat a type ii endoleak sac in the inferior mesenteric artery (ima) using ruby coil lps, packing coil lps, lp system detachment handle (handle), lantern delivery microcatheter (lantern), non-penumbra microcatheter, and a non-penumbra diagnostic catheter.During the procedure, the physician experienced resistance while advancing a lantern through the diagnostic catheter and the lantern became stuck.The lantern was removed and a new microcatheter was used.The physician then attempted to detach a first packing coil lp using a handle; however, the packing coil lp failed to detach.The physician used a new handle; however, the packing coil lp still failed to detach.A hemostat was used to manually detach the coil.The physician then attempted to advance a second packing coil lp; however, the packing coil lp would not advance past the friction lock within its introducer sheath.The physician attempted to advance a third packing coil lp but, the same issue occurred.A fourth packing coil lp was advanced to the target location but had difficulty detaching.Therefore, the physician used a hemostat to manually detach the coil.A fifth packing coil lp would not advance past the friction lock and consequently, the pusher assembly of the packing coil lp became kinked.The physician then attempted to detach ruby coil lp using a handle but, the coil failed to detach.The coil was then manually detached in the target vessel.The procedure had ended at this point.There was no report of an adverse effect to the patient.
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Manufacturer Narrative
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Evaluation of the returned lantern revealed that the catheter was kinked.If the lantern is forcefully advanced against resistance, damage such as this may occur.During the functional test, resistance was encountered while advancing the returned lantern and a demonstration lantern through the non-penumbra guide catheter, and neither lantern could be advanced through.The root cause of resistance could not be determined.Evaluation of the first returned packing coil lp could not confirm the reported advancement issue.Evaluation of the returned packing coil lp revealed that the pusher assembly was fractured, and the embolization coil was detached.This damage was incidental to the reported complaint, and based on the returned condition, the root cause could not be determined.The distal fractured segment of the pusher assembly and embolization coil were not returned for evaluation.Evaluation of the second returned packing coil lp revealed that the pusher assembly mid-joint was retracted through the introducer sheath friction lock.If this occurs, resistance may be experienced during advancement.Forceful advancement against this resistance likely contributed to the kink observed near the pusher assembly mid-joint.During functional testing, the pusher assembly mid-joint was unable to be advanced through the introducer sheath friction due to the kink in the pusher assembly near the mid-joint, and no further functional testing could be performed.Penumbra devices are visually inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 1.3005168196-2021-01095, 2.3005168196-2021-01096, 3.3005168196-2021-01097, 4.3005168196-2021-01098, 5.3005168196-2021-01099, 6.3005168196-2021-01100, 7.3005168196-2021-01101, 8.3005168196-2021-01102 h3 other text : placeholder.
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Search Alerts/Recalls
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