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Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, ethnicity, and medical history were not provided.The initial reporter phone is not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.The image included in the complaint underwent independent physician review on 30 march 2021.The result of the review is as following: "the case form and two images are submitted for review.An embovac was used for an attempted adapt aspiration thrombectomy through a neuron max by snaking the embovac to the posterior genu of the cavernous segment where resistance was felt and upon withdrawing the embovac further resistance was noted and upon removal of the embovac the distal tip was noted to be stretched.No images of the catheter, distal tip or guide catheter/sheath are provided.There is mild tortuosity of the distal cervical ica and a tight turn of the posterior genu of the cavernous ica.Likely while advancing the embovac without an intermediate catheter or wire the catheter may have bent at the posterior genu, further while withdrawing this bend may have caught on the neuron max causing stretching of the catheter.Bending or kinking of the catheter as well as stretching of the catheter are known complications especially in the setting of advancing without an inner catheter/wire as well as at times because of tortuosity and kinking of catheters.The friction between two catheter systems may occur and stretching of the catheter may happen.No clinical sequelae as the physician were able to complete to case with a smaller catheter." physician name and date reviewed: (b)(6).3/30/2021.A review of manufacturing documentation associated with this lot (30456365) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The code ¿no device problem found¿ code was used in investigation findings to indicate that the device issue reported was not found as the photos included are angiograph images of the procedure.The complaint device has not been received.This code corresponds with the ¿no problem detected¿ code used in the investigation conclusions.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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The healthcare professional reported that during a thrombectomy procedure that was targeting a distal m1 occlusion in the left middle cerebral artery (mca), with the intended case being a direct aspiration first pass technique (adapt), the 132cm embovac 71 aspiration catheter (ic71132ca / 30456365) was used in a patient with ¿very elongated vessels¿ with acute bends.The 132cm embovac 71 aspiration catheter was snaked up to the noted position in the image included in the complaint, the rebar¿ 18 microcatheter (medtronic) and the transend¿ 0.014 guidewire (stryker) was planned to be used as the embovac would not go further easily.During the retraction attempt into the neuron max® 088 sheath (penumbra), the distal area of the embovac became stretched.The physician suspected that the embovac device got caught or snagged on the tip of the neuron max.There was no damage noted on the neuron max.The reported issue resulted in a 10-minute procedure delay.The procedure was successfully completed with the ace¿ 68 reperfusion catheter (penumbra) instead of the embovac; it was completed without any reported patient adverse event or complication.
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a thrombectomy procedure that was targeting a distal m1 occlusion in the left middle cerebral artery (mca), with the intended case being a direct aspiration first pass technique (adapt), the 132cm embovac 71 aspiration catheter (ic71132ca / 30456365) was used in a patient with ¿very elongated vessels¿ with acute bends.The 132cm embovac 71 aspiration catheter was snaked up to the noted position in the image included in the complaint, the rebar¿ 18 microcatheter (medtronic) and the transend¿ 0.014 guidewire (stryker) was planned to be used as the embovac would not go further easily.During the retraction attempt into the neuron max® 088 sheath (penumbra), the distal area of the embovac became stretched.The physician suspected that the embovac device got caught or snagged on the tip of the neuron max.There was no damage noted on the neuron max.The reported issue resulted in a 10-minute procedure delay.The procedure was successfully completed with the ace¿ 68 reperfusion catheter (penumbra) instead of the embovac; it was completed without any reported patient adverse event or complication.The image included in the complaint underwent independent physician review on 30 march 2021.The result of the review is as following: "the case form and two images are submitted for review.An embovac was used for an attempted adapt aspiration thrombectomy through a neuron max by snaking the embovac to the posterior genu of the cavernous segment where resistance was felt and upon withdrawing the embovac further resistance was noted and upon removal of the embovac the distal tip was noted to be stretched.No images of the catheter, distal tip or guide catheter/sheath are provided.There is mild tortuosity of the distal cervical ica and a tight turn of the posterior genu of the cavernous ica.Likely while advancing the embovac without an intermediate catheter or wire the catheter may have bent at the posterior genu, further while withdrawing this bend may have caught on the neuron max causing stretching of the catheter.Bending or kinking of the catheter as well as stretching of the catheter are known complications especially in the setting of advancing without an inner catheter / wire as well as at times because of tortuosity and kinking of catheters.The friction between two catheter systems may occur and stretching of the catheter may happen.No clinical sequelae as the physician were able to complete to case with a smaller catheter." physician name and date reviewed: imran chaudry, mbbs.3/30/2021 the complaint device was returned for evaluation and analysis.It was received on 06 july 2021.The investigational finding is documented below.Investigation summary: the non-sterile 132cm embovac 71 aspiration catheter was received contained in a pouch.Visual inspection was performed.The returned device was observed kinked at 1 inch, 15 inches, and 38 inches.The device is observed in a compressed condition at 21 to 22 inches.The braided mesh was observed compressed.No other damages nor anomalies were observed.Dimensional evaluation: the inner diameter (id) and outer diameter (od) of the device were measured and found to be within specification.Hub id = 0.0715 inch; specification: 0.071 inch minimum.Distal id = 0.0715 inch ; specification: 0.071 inch minimum.Actual microcatheter od = 0.0834 inch; specification: max.= 0.0837¿ / min.0.081 inch.A review of manufacturing documentation associated with this lot (30456365) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.The complaint documented that the 132cm embovac 71 aspiration catheter was used in a patient with ¿very elongated vessels¿ with acute bends.The embovac catheter was snaked up to position, the rebar¿ 18 microcatheter (medtronic) and the transend¿ 0.014 guidewire (stryker) was planned to be used as the embovac would not go further easily.During the retraction attempt into the neuron max® 088 sheath (penumbra), the distal area of the embovac became stretched.The physician suspected that the embovac device got caught or snagged on the tip of the neuron max.Visual inspection performed on the returned device noted that the embovac was kinked in three areas (at 1 inch, 15 inches, and 38 inches), the braided mesh was in a compressed condition at 21 to 22 inches.The observations made during the visual inspection confirmed the reported issue documented in the complaint.The exact cause of the reported issue cannot be conclusively determined; however, the observations made during the visual inspection are consistent with the independent physician review of the image included in the complaint, that ¿bending or kinking of the catheter as well as stretching of the catheter are known complications especially in the setting of advancing without an inner catheter / wire as well as at times because of tortuosity and kinking of catheters.The friction between two catheter systems may occur and stretching of the catheter may happen.¿ the issue related to withdrawal difficulty encountered during the attempt to retract the device into the neuron max® 088 sheath could not be confirmed through analysis and evaluation as the issue is uniquely dependent on the patient anatomy and the circumstance of the procedure at the time of its encounter / occurrence.The issue cannot be replicated in a laboratory environment.However, the compressed condition observed on the braided mesh could likely be a contributing factor to the withdrawal difficulty issue as reported in the complaint.The confirmation of the issue is based on the visual observation of the condition of the braided mesh; the exact cause cannot be conclusively determined.It should be noted that product failure is multifactorial.Although no conclusion could be reach on the cause of the reported event, the instructions for use (ifu) contains the following precaution: ¿ exercise care in handling the embovac catheter to reduce the chance of accidental damage.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
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