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

Catalog Number ET007533

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint#: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a thrombectomy case, it was impossible to move a 5x33 embotrap ii revascularization device ((b)(4)) through a headway 21 microcatheter (mc).When using another embotrap 33mm, it passed well.This one could be moved throughout the same microcatheter without difficulties.Clot was removed within 3 minutes.There was no patient injury reported.Additional information received indicated that the cause of the event, or factors contributing to the event known is not known.No excessive force was applied to the device.The device was used, and prepped as per the instructions for use (ifu).However, the device was not inspected for damage prior to use since, ¿too little time in a thrombectomy." during use, the microcatheter, and the embotrap did not appear damaged.The insertion tool was securely placed in the hub of the microcatheter prior to attempting to advance the embotrap.The technique used to hold the insertion tool in position during the advancement of the device was rhw tightened.The user held the insertion tool firmly in place and the assistant gently pushed.The device was flushed without difficulty.The device did not inadvertently deploy in the microcatheter hub.The insertion tool in the hub, the embotrap did not pass into the mc.No attempts were made to pass with the complaint device due to the event.The initial examination of the returned embotrap device identified deformation of the distal cone (inner channel and outer cage).There was no evidence of any strut fractures.The visual inspection also indicates that the return embotrap 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 both inner channel and outer cage is indicative of excessive pushing of the device against resistance.The damage is consistent with attempted delivery into a microcatheter against significant resistance.The most probable causes of the failure to advance through the microcatheter are either a failure to seat the insertion tool fully into the microcatheter hub prior to advancing the device (a failure to maintain the insertion tool in a fully seated position whilst advancing the device, and caused pre-deployment of the device in the microcatheter hub).A blockage or constriction in the microcatheter hub/lumen, likely to be located at the interface of the microcatheter hub and shaft.The return embotrap device was successfully passed through a "0.0195 tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.The ptfe insertion tool was dimensionally inspected and found to be within specification for the inner diameter and outer diameter.Device insertion and delivery assessments were performed using the return embotrap device and a sample headway 21 microcatheter (microvention terumo, mc212156s, lot no.190108132), however, the returned device failed to advance from the insertion tool into the proximal lumen of the headway 21 microcatheter due to the damage.A new sample of embotrap device (ø5x33mm, lot no.19j131av) was advanced to the same sample headway 21 microcatheter with the insertion tool fully seated in the microcatheter hub and with gaps (i.E.Distance from the distal end of the insertion tool to the lumen at the proximal end of the microcatheter shaft).It was confirmed that advancement was unsuccessful at a gap greater than 15mm, i.E.Incorrectly seated.Then the same sample of embotrap device was attempted to be damaged to replicate the similar deformation confirmed with the returned device.The sample embotrap device was advanced to the same sample headway 21 microcatheter.When the gap between the distal end of insertion tool and the proximal lumen of microcatheter was 1mm (i.E.Fully seated), the resistance was confirmed, however, the advancement was successful.When the gap was increased to 5mm, the insertion was unsuccessful.This demonstrates that the deformation at the distal cone makes resistance and delivery more difficult.As the deformation is consistent with attempted delivery through a constricted lumen the most probable root cause(s).Therefore, is either a localized temporary constriction in the proximal end of the microcatheter existed that prevented delivery of the return embotrap device (i.E.Such as a kink or constriction in the lumen potentially due to excessive angulation of the proximal end of the microcatheter) or the rhv seal was not fully tightened, thereby, allowing some movement of the insertion tool in the rhv during device delivery.A review of the manufacturing documentation associated with lot number 20f024av presented no issues during the manufacturing or inspection process that can be related to the reported event.The reported customer complaint, ¿embotrap - impeded in mc without loss of cerebral target position,¿ was confirmed.The returned embotrap device exhibits key characteristics, which are consistent with the advancement of the device against significant resistance.Although a visual examination of the microcatheter used during this complaint was not possible as the microcatheter was not returned for investigation, the most probable root cause(s) of the confirmed deformation would be that either a localized, temporary constriction in the proximal end of the microcatheter existed that prevented delivery of the return embotrap device (i.E.Such as a kink or constriction in the lumen potentially due to excessive angulation of the proximal end of the microcatheter) or the rhv seal was not fully tightened thereby allowing some movement of the insertion tool in the rhv during device delivery.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

Event Description

As reported by the field, during a thrombectomy case, it was impossible to move a 5x33 embotrap ii revascularization device ((b)(4)) through a headway 21 microcatheter (mc).When using another embotrap 33mm, it passed well.This one could be moved throughout the same microcatheter without difficulties.Clot was removed within 3 minutes.There was no patient injury reported.Additional information received indicated that the cause of the event or factors contributing to the event known is not known.No excessive force was applied to the device.The device was used and prepped as per the instructions for use (ifu).However, the device was not inspected for damage prior to use since, ¿too little time in a thrombectomy." during use, the microcatheter and the embotrap did not appear damaged.The insertion tool was securely placed in the hub of the microcatheter prior to attempting to advance the embotrap.The technique used to hold the insertion tool in position during the advancement of the device was rhw tightened.The user held the insertion tool firmly in place and the assistant gently pushed.The device was flushed without difficulty.The device did not inadvertently deploy in the microcatheter hub.The insertion tool in the hub, the embotrap did not pass into the mc.No attempts were made to pass with the complaint device due to the event.Based on the product analysis, the outer cage, and inner channel of the device received are kinked.

• 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: 10710899
• MDR Text Key: 212295781
• Report Number: 3011370111-2020-00077
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: ET007533
• Device Lot Number: 20F024AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEADWAY 21 MICROCATHETER
• Patient Age: 79 YR