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 10/11/2019

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 initial reporter phone is not available / reported.[conclusion]: the healthcare professional reported that during the mechanical thrombectomy procedure, the physician inserted the 5mm x 33 mm embotrap ii revascularization device (et007533 / 19g123av) was introduced in the hub of the headway® 21 microcatheter ((b)(4)), but the embotrap device became stuck and could not be advanced forward.It was reported that the distal end of the insertion tool was inserted through the rotating hemostasis valve (rhv) and flushed until liquid was visible at the proximal end.However, the physician thought that the insertion tool did not sit tight enough with the headway microcatheter hub and there was some open space which caused the embotrap to open a little and did not fit into the microcatheter as the insertion tool could not go further.Adequate and continuous flush was maintained.The embotrap device did not go into the patient¿s anatomy; it was stuck at the hub of the microcatheter.There was no report of any kink or bend on the microcatheter.The physician used the trevo® retriever ((b)(4)) with the headway microcatheter to complete the procedure.There was no report of any patient injury or adverse event 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 concomitant headway 21 microcatheter was also returned with its pouch.The returned device visual inspection.The initial examination of the returned embotrap device identified deformation of the distal cone (outer cage and inner channel) and distal tip (distal coil) 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 when the insertion tool is not fully seated or moves proximally during device insertion.The damage to the distal tip is indicative of withdrawing the embotrap through a closed rhv and was concluded to not effect deliverability of the device when the device is correctly seated and occurring after the failed attempted delivery.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 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 failure to seat the insertion tool fully into the microcatheter hub prior to advancing the device (or a failure to maintain the insertion tool in a fully seated position whilst advancing the device) or a permanent or temporary constriction in the microcatheter hub/lumen, in this case 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 the returned headway 21 microcatheter.The returned device successfully advanced from the insertion tool into the lumen of the headway 21 microcatheter in a fully seated position with no noted resistance, this indicates that the device and microcatheter performed as expected, i.E.The damage to the device does not prevent delivery of the device and the microcatheter lumen was patent.The effect of variation in seating of the insertion in the microcatheter was investigated with gaps between the distal end of the insertion tool and distal part of hub lumen.Device delivery was found to be successful with gaps of 5mm and 8mm from the microcatheter lumen.At 10mm the returned device failed to deliver into the returned microcatheter due to the damage on the device.An un-used embotrap was then advanced into the microcatheter 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 14mm.Advancement was unsuccessful at a gap greater than 14mm, i.E.Incorrectly seated.No distal tip damage was noted after the unsuccessful attempt to insert the embotrap.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.It also stated that another device was then passed through the returned microcatheter and the procedure completed successfully.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 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 device history record (dhr) associated with this lot (19g123av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances 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 returned and there was no damage noted, 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 constriction in the lumen potentially due to excessive angulation of the proximal end of the microcatheter) or the insertion tool seating was not optimal, caused by 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.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 mechanical thrombectomy procedure, the physician inserted the 5mm x 33 mm embotrap ii revascularization device (et007533 / 19g123av) was introduced in the hub of the headway® 21 microcatheter (microvention-terumo), but the embotrap device became stuck and could not be advanced forward.It was reported that the distal end of the insertion tool was inserted through the rotating hemostasis valve (rhv) and flushed until liquid was visible at the proximal end.However, the physician thought that the insertion tool did not sit tight enough with the headway microcatheter hub and there was some open space which caused the embotrap to open a little and did not fit into the microcatheter as the insertion tool could not go further.Adequate and continuous flush was maintained.The embotrap device did not go into the patient¿s anatomy; it was stuck at the hub of the microcatheter.There was no report of any kink or bend on the microcatheter.The physician used the trevo® retriever ((b)(4)) with the headway microcatheter to complete the procedure.There was no report of any patient injury or adverse event as a result of the reported issue.The 5mm x 33 mm embotrap ii device was returned for evaluation which revealed deformation of the distal cone (on the outer cage and the inner channel) and on the distal tip (distal coil).Based on the product analysis on 12/16/2019, 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: 9507873
• MDR Text Key: 219779586
• Report Number: 3011370111-2019-00172
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 10/11/2019

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: 04/17/2022
• Device Catalogue Number: ET007533
• Device Lot Number: 19G123AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2019
• Initial Date FDA Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2019
• 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