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 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # :(b)(4).The purpose of this mdr submission is to report the findings of the device investigation.Based on the analysis of the device involved, the inner channel and outer cage of the device is 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 name, occupation, phone, fax, and e-mail address, was not reported.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.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 filed, during a stroke, the physician tried to introduce a 5x33 embotrap ii revascularization device (et007533, 19l100av) into a headway 21 microcatheter (mc), but it did not work.In the hub the embotrap started to compress in-between the hub of the mc and the introducing sheath.There was no report of patient injury.There was no loss of cerebral target position since it was not even possible to bring the embotrap inside the mc.Another stent retriever was used.There was no damage to the mc.The physician was not able to push the embotrap trough the point between our insertion tool and the end of the mc.The technique used to hold the insertion tool in position during advancement of the device was by with the left hand the doctor held the y valve and with the right hand he held the insertion tool and pushed the wire of the device forward.There were difficulties flushing the device.The embotrap inadvertently deployed in the microcatheter hub due to the resistance.Another device was able to pass through the same microcatheter after the issue with the embotrap.The initial examination of the returned embotrap device identified deformation of the distal cone and proximal struts (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 proximal struts of both outer cage and inner channel, is indicative of excessive pushing of the device against resistance.The damage to the proximal struts 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 outer diameter (od) and inner diameter (id).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 due to the damage that was present on the proximal struts of the device.A new embotrap was then advanced with no noted resistance and successfully delivered through the entire length of the microcatheter.This demonstrates that minor variations in seating the insertion tool in the microcatheter hub does not adversely impact the advancement of the embotrap device into the catheter.However, significant variation (>14mm) due to poor seating or movement of the insertion tool (failing to tighten the rhv) may impact advancement.Advancement was unsuccessful at a gap greater than 14mm, i.E.Incorrectly seated.The complaint indicated that the returned device was unsuccessfully passed through the headway 21 microcatheter by the physician leading to failure to deliver the embotrap device.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.A review of the manufacturing documentation associated with lot number 19l100av presented no issues during the manufacturing or inspection process that can be related to the reported event.The return embotrap device exhibits key characteristics that 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.Neither the device history record review nor the product analysis suggest that the reported failure could be related to the manufacturing process of the unit.Per the instructions for use (ifu), 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 events remains speculative and inconclusive, based on the 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 observed on the returned device 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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

Event Description

As reported by the filed, during a stroke, the physician tried to introduce a 5x33 embotrap ii revascularization device (et007533, 19l100av) into a headway 21 microcatheter (mc), but it did not work.In the hub the embotrap started to compress in-between the hub of the mc and the introducing sheath.There was no repot of patient injury.There was no loss of cerebral target position since it was not even possible to bring the embotrap inside the mc.Another stent retriever was used.There was no damage to the mc.The physician was not able to push the embotrap trough the point between our insertion tool and the end of the mc.The technique used to hold the insertion tool in position during advancement of the device was by with the left hand the doctor held the y valve and with the right hand he held the insertion tool and pushed the wire of the device forward.There was difficulties flushing the device.The embotrap inadvertently deployed in the microcatheter hub due to the resistance.Another device was able to pass through the same microcatheter after the issue with the embotrap.Based on the analysis of the device involved, the inner channel and outer cage of the device is kinked.

• Brand Name: EMBOTRAP II 5X33 REVASC. DEV.
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; 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: 10042695
• MDR Text Key: 240396739
• Report Number: 3011370111-2020-00042
• 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: Other
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/16/2022
• Device Catalogue Number: ET007533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Date Manufacturer Received: 04/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• 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