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 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The outer cage and the nner channel of the device are kinked, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter: the customer contact information, including phone, fax, and e-mail address, was not reported.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 (et007533, 20b036av) through the headway 21 microcatheter (mc).When using another embotrap 33mm, it passed well.This new one was able to move throughout the microcatheter without difficulties.The complaint device was not able to advance through the hub.There was no patient injury reported.The patient¿s current condition was reported as being ¿ok¿, not influenced by the event.The device was used and prepped as per the instructions for use.The device was set up as identical to other cases.There was no excessive force applied to the device.The device was inspected for damage after the first failed attempt.Everything appeared normal.The insertion tool was securely placed in the hub of the microcatheter prior to attempting to advance the embotrap.The device was flushed without difficulty.Another physician held the insertion tool in position during advancement of the device.The mc appeared damaged after several attempts with embotrap.The device was not inadvertently deployed in the microcatheter hub.Based on the device analysis, the outer cage and the inner channel were noted to being kinked.The initial examination of the returned embotrap device identified deformation of the distal cone (outer cage and inner channel) but 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 outer cage and inner channel 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 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.The damage to the return embotrap device 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) 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) b) a constriction in the microcatheter hub/lumen, likely to be located at the interface of the microcatheter hub and shaft.Device insertion and delivery assessments were performed using the return embotrap device and a sample headway 21 microcatheter, however the returned device failed to advance from the insertion tool into the lumen of the headway 21 microcatheter.A new embotrap was then advanced with no noted resistance and successfully delivered through the entire length of the microcatheter.This was confirmed with the insertion tool fully seated in the microcatheter hub and also with gaps (i.E.Distance from the distal end of the insertion tool to the lumen at the proximal end of the microcatheter shaft) of up to 15mm.Advancement was unsuccessful at a gap greater than 15mm, i.E.Incorrectly seated.As the damage 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.The return embotrap device exhibits key characteristics which are consistent with 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) 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.There is no indication that this complaint was as a result of a defect with the embotrap device.The instructions for use (ifu) indicate to insert the distal end of the insertion tool through the rhv of the microcatheter and wait until fluid is seen exiting the proximal end of the insertion tool, confirming that the device is flushed.Advance the insertion tool until it is fully seated in the hub of the microcatheter.Fully tighten the rhv to hold the insertion tool securely in position.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.The damage noted during the visual inspection under magnification i.E.Kinked struts on the distal cone of both outer cage and inner channel is indicative of excessive pushing of the device against resistance.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 (et007533, 20b036av) through the headway 21 microcatheter (mc).When using another embotrap 33mm, it passed well.This new one was able to move throughout the microcatheter without difficulties.The device was not able to advance through the hub.There was no patient injury reported.The patient¿s current condition was reported as being ¿ok¿, not influenced by the event.The device was used and prepped as per the instructions for use.The device was set up as identical to other cases.There was no excessive force applied to the device.The device was inspected for damage after the first failed attempt.Everything appeared normal.The insertion tool was securely placed in the hub of the microcatheter prior to attempting to advance the embotrap.The device was flushed without difficulty.Another physician held the insertion tool in position during advancement of the device.The mc appeared damaged after several attempts with embotrap.The device was not inadvertently deployed in the microcatheter hub.Based on the device analysis, the outer cage and the inner channel were noted to being 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: 10401702
• MDR Text Key: 242162089
• Report Number: 3011370111-2020-00061
• 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: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2023
• Device Catalogue Number: ET007533
• Device Lot Number: 20B036AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• 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
• Patient Age: 79 YR