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 10/13/2019

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.The name, phone and email address of the initial reporter are not available / reported.[conclusion]: the healthcare professional reported that during an intra-arterial thrombectomy procedure, the physician passed the 5mm x 33 mm embotrap ii revascularization device (et007533 / 19e002av) through the carotid occlusion via the vasco 21 microcatheter (balt).After the microcatheter hub was flushed, the physician advanced the embotrap ii device but suddenly felt a lot of resistance just at the last part of the cage (last of the 5 cages).It was reported that only the embotrap device was initially advanced and the physician never had any issues with this before, however, now, this method did not work.The physician advanced the embotrap device with the sheath fixed to the microcatheter hub but still could not advance the embotrap.There was no kink on the vasco 21 microcatheter.The valves of the co-pilots were not extremely rotated.Another 5mm x 33 mm embotrap ii device was used with the same vasco 21 microcatheter and it advanced smoothly through the microcatheter.There was no report of any patient adverse event or complication as a result of the reported issue.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the embotrap ii device was returned with the insertion tool and tyvek pouch.The original product packaging (i.E.Unit carton), hoop, and instruction for use (ifu) were not returned.The initial examination of the returned embotrap device identified deformation of the proximal struts (outer cage) but there was no evidence of any strut fractures.The visual inspection also indicates that the returned 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 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 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).The damage to the returned 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).Or b) a temporary 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 both the returned embotrap device and an unused embotrap device and a new vasco+21mp microcatheter.The returned device successfully advanced from the insertion tool into the lumen of the vasco+21mp microcatheter in a fully seated position with no additional resistance noted.At 5mm the returned device failed to deliver into the microcatheter due to the damage the device caused by the original attempt to advance against resistance.An un-used 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 with variation in seating (i.E.Increasing gap distance from the distal end of the insertion tool to the lumen at the proximal end of the microcatheter shaft) of up to 10mm.Advancement was unsuccessful at a gap greater than 10mm, i.E.Incorrectly seated.The complaint indicated that the majority of the device delivered successfully until the last section this is likely due to some movement of the insertion tool at the final point of delivery.The complaint also indicates another embotrap device and delivered through the same microcatheter successfully.As the damage is indicative of excessive pushing of the device against resistance the most probable root cause(s) from this investigation therefore is the rhv seal was not fully tightened thereby allowing some movement of the insertion tool in the rhv during device delivery.This would cause the proximal struts to kink and failure to deliver the device.A review of the device history (dhr) records confirms that there were no issues with the assembly of the lot 19e002av (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.Conclusion: the return embotrap 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 not possible as it wasn¿t returned.From this investigation the most probable root cause(s) would be that the insertion tool seating was not optimal, caused by the placement by the physician or by the rhv seal not being 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.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.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 an intra-arterial thrombectomy procedure, the physician passed the 5mm x 33 mm embotrap ii revascularization device (et007533 / 19e002av) through the carotid occlusion via the vasco 21 microcatheter (balt).After the microcatheter hub was flushed, the physician advanced the embotrap ii device but suddenly felt a lot of resistance just at the last part of the cage (last of the 5 cages).It was reported that only the embotrap device was initially advanced and the physician never had any issues with this before, however, now, this method did not work.The physician advanced the embotrap device with the sheath fixed to the microcatheter hub but still could not advance the embotrap.There was no kink on the vasco 21 microcatheter.The valves of the co-pilots were not extremely rotated.Another 5mm x 33 mm embotrap ii device was used with the same vasco 21 microcatheter and it advanced smoothly through the microcatheter.There was no report of any patient adverse event or complication as a result of the reported issue.The 5mm x 33 mm embotrap ii device was returned for evaluation which revealed deformation of the proximal struts (outer cage).Based on the product analysis on 12/17/2019, 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: 9508052
• MDR Text Key: 219597394
• Report Number: 3011370111-2019-00174
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2019

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: 01/16/2022
• Device Catalogue Number: ET007533
• Device Lot Number: 19E002AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2019
• 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