MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Model Number ET009533

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, ethnicity, and medical history were not provided.[conclusion]: the healthcare professional reported that during the thrombectomy procedure, the 5mm x 33mm embotrap ii revascularization device (et009533 / 19f151av) would not advance into the sl-10® microcatheter (stryker).There was difficulty pushing the embotrap device out of the introducer sheath.The insertion tool was placed securely at the hub of the microcatheter, the rotating hemostasis valve (rhv) was not tightened during the advancement of the insertion tool and delivery of the embotrap device.There was no issue with flushing the device; the device would not advance past the insertion tool.It was confirmed that there was no kinking observed on the microcatheter.The embotrap device was removed from the microcatheter and a second 5mm x 33mm embotrap ii revascularization device (et009533 / 19f019av) was used and the same issue occurred; the device would not advance past the insertion tool.It was reported that the 4mm x 40mm solitaire¿ revascularization device (medtronic) was successfully passed through the same concomitant microcatheter.The clot was removed with a total of three passes; there were two aspiration passes made with the solitaire device.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the initial examination of the returned embotrap ii device identified slight deformation of the struts of the distal cone (outer cage only) but there was no evidence of any strut fractures.The visual inspection also indicates that the return embotrap ii device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The damage noted during the visual inspection under magnification i.E.Kinked struts on the distal cone of the outer cage is indicative of excessive pushing of the device against resistance.The damage to the struts of the distal cone is indicative of a blockage or constriction of the inner lumen of the microcatheter or pre-deployment of the device in the microcatheter hub as the insertion tool may not have been fully seated.The return embotrap ii device was successfully passed through a 0.0195¿ tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.The polytetrafluoroethylene (ptfe) insertion tool was dimensionally inspected and found to be within specification for the outer diameter (od) and inner diameter (id).The complaint indicated that the returned device was unsuccessfully passed through the lumen of a sl-10 microcatheter by the physician leading to failure to deliver the embotrap ii device.The inner diameter of this kind of microcatheter is 0.0165¿ which is too small and incompatible with embotrap ii.This is the cause of the failure to deliver the returned embotrap device.Device insertion and delivery assessments were performed using the return embotrap ii device and a sample 0.021¿ microcatheter (prowler select plus), the returned device successfully advanced from the insertion tool into the lumen of the prowler select plus microcatheter when fully seated.This indicates that there was no functional defect with the returned embotrap ii device as the damaged device delivered successfully.A new embotrap ii failed to advance into a new sl-10 microcatheter showing that embotrap is incompatible with this microcatheter due to the smaller inner lumen diameter.As the damage is consistent with attempted delivery through a reduced lumen the root cause therefore is that the microcatheter used in the procedure was too small and incompatible for use with the embotrap ii device.A review of the device history (dhr) records confirms that there were no issues with the assembly of the lot 19f151av (sub and top assembly).There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Investigation conclusion: the return embotrap ii device exhibits key characteristics which are consistent with advancement of the device against significant resistance.A visual examination of the microcatheter used during this complaint was completed and nothing was found to suggest any defect or malfunction, the root cause is that the microcatheter used in the procedure was incompatible, i.E.Smaller than the indicated 0.021¿ inner diameter, with the embotrap ii device.There is no indication that this complaint was as a result of a defect with the embotrap ii device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3011370111-2020-00036 and 3011370111-2020-00037.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.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.

Event Description

The healthcare professional reported that during the thrombectomy procedure, the 5mm x 33mm embotrap ii revascularization device (et009533 / 19f151av) would not advance into the sl-10® microcatheter (stryker).There was difficulty pushing the embotrap device out of the introducer sheath.The insertion tool was placed securely at the hub of the microcatheter, the rotating hemostasis valve (rhv) was not tightened during the advancement of the insertion tool and delivery of the embotrap device.There was no issue with flushing the device; the device would not advance past the insertion tool.It was confirmed that there was no kinking observed on the microcatheter.The embotrap device was removed from the microcatheter and a second 5mm x 33mm embotrap ii revascularization device (et009533 / 19f019av) was used and the same issue occurred; the device would not advance past the insertion tool.It was reported that the 4mm x 40mm solitaire¿ revascularization device (medtronic) was successfully passed through the same concomitant microcatheter.The clot was removed with a total of three passes; there were two aspiration passes made with the solitaire device.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation.During the visual / microscopic inspection of the returned device, the struts of the outer cage of the embotrap device were observed kinked at the distal cone.Based on the product analysis 4/28/2020, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3; ballybritt business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): ADVANT MEDICAL; parkmore business park west; galway H91 P V0V; EI H91 PV0V
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10022619
• MDR Text Key: 240383790
• Report Number: 3011370111-2020-00036
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: 10886704081326
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Model Number: ET009533
• Device Catalogue Number: ET009533
• Device Lot Number: 19F151AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1