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 11/16/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.The name, phone and email address of the initial reporter are not available / reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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 nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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 the mechanical thrombectomy procedure, the 5mm x 33cm embotrap ii revascularization device (et007533 / 19e002av) was not able to advance into the rebar¿ 18 microcatheter (medtronic) in the rotating hemostat valve (rhv) hub.The introducer sheath was put in place correctly, and when the embotrap device was withdrawn, it had a kink at the joint between the delivery wire and the device.Another 5mm x 33cm embotrap ii device was used as a replacement and the replacement device was able to advance into the microcatheter and remove the clot.There was no report of any patient injury or complication.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 12/19/2019.Multiple attempts to obtain product for analysis were unsuccessful.If product is returned at a later date, the file will be updated accordingly.[conclusion]: the healthcare professional reported that during the mechanical thrombectomy procedure, the 5mm x 33cm embotrap ii revascularization device (et007533 / 19e002av) was not able to advance into the rebar¿ 18 microcatheter (medtronic) in the rotating hemostat valve (rhv) hub.The distal end of the insertion tool was inserted through the rhv and flushed until liquid was visital at the proximal end.It was confirmed that the insertion tool was fully seated in the hub of the rhv before the physician proceeded to advance the device.Continuous flush was maintained through the microcatheter, but the device was stuck and was unable to be advanced in the microcatheter.The introducer sheath was put in place correctly, when the embotrap device was withdrawn, it had a kink at the joint between the delivery wire and the device.Another 5mm x 33cm embotrap ii device was used as a replacement and the replacement device was able to advance into the microcatheter and remove the clot.It was reported that there was no kink on the microcatheter; the microcatheter was not removedthe same microcatheter was used with the replacement embotrap device to complete the procedure.There was no report of any patient injury or complication.Multiple attempts to obtain product for analysis were unsuccessful.If product is returned at a later date, the file will be updated accordingly.Based on complaint information, the device was not available to be returned for analysis.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.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and/or device manipulation / interaction may have contributed to the reported failure.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.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.

Manufacturer Narrative

Manufacturer¿s ref.(b)(4).The purpose of this mdr is to include the additional event information received on 12/10/2019.[additional information]: the healthcare professional reported that during the mechanical thrombectomy procedure, the 5mm x 33cm embotrap ii revascularization device (et007533 / 19e002av) was not able to advance into the rebar¿ 18 microcatheter (medtronic) in the rotating hemostat valve (rhv) hub.The distal end of the insertion tool was inserted through the rhv and flushed until liquid was visital at the proximal end.It was confirmed that the insertion tool was fully seated in the hub of the rhv before the physician proceeded to advance the device.Continuous flush was maintained through the microcatheter, but the device was stuck and was unable to be advanced in the microcatheter.The introducer sheath was put in place correctly, when the embotrap device was withdrawn, it had a kink at the joint between the delivery wire and the device.Another 5mm x 33cm embotrap ii device was used as a replacement and the replacement device was able to advance into the microcatheter and remove the clot.It was reported that there was no kink on the microcatheter; the microcatheter was not removedthe same microcatheter was used with the replacement embotrap device to complete the procedure.There was no report of any patient injury or complication.(b)(4).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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the mechanical thrombectomy procedure, the 5mm x 33cm embotrap ii revascularization device (et007533 / 19e002av) was not able to advance into the rebar¿ 18 microcatheter (medtronic) in the rotating hemostat valve (rhv) hub.The distal end of the insertion tool was inserted through the rhv and flushed until liquid was visital at the proximal end.It was confirmed that the insertion tool was fully seated in the hub of the rhv before the physician proceeded to advance the device.Continuous flush was maintained through the microcatheter, but the device was stuck and was unable to be advanced in the microcatheter.The introducer sheath was put in place correctly, when the embotrap device was withdrawn, it had a kink at the joint between the delivery wire and the device.Another 5mm x 33cm embotrap ii device was used as a replacement and the replacement device was able to advance into the microcatheter and remove the clot.It was reported that there was no kink on the microcatheter; the microcatheter was not removed the same microcatheter was used with the replacement embotrap device to complete the procedure.There was no report of any patient injury or complication.The product was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the initial examination of the returned embotrap device identified deformation of the 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 on both the 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 polytetrafluoroethylene (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) 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 hub/lumen of the microcatheter used in the procedure, 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 rebar¿ 18 microcatheter, the returned device successfully advanced from the insertion tool into the lumen of the microcatheter in its fully seated position but failed to deliver when the distance was increased to 5mm for the microcatheter lumen.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 8mm in the rebar¿ 18 microcatheter.Advancement was unsuccessful at a gap greater than 10mm, i.E.Incorrectly seated.The complaint indicated that the physician was unable to deliver the returned embotrap device through a rebar¿ 18 microcatheter.Another embotrap device was taken and deliver successfully and the procedure was completed, removing the clot.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 rotating hemostasis valve (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 (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.Investigation conclusion: 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.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.Updated sections: g.4, g.7, h.2, h.3, h.6, and h.10.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.

Manufacturer Narrative

Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to report that the product was received by the product analysis lab on 2/7/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

• 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
• MDR Report Key: 9440914
• MDR Text Key: 205910843
• Report Number: 3011370111-2019-00169
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/19/2019

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: 11/21/2019
• Device Catalogue Number: ET007533
• Device Lot Number: 19E002AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Manufacturer Received: 11/19/2019
• Initial Date FDA Received: 12/09/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 12/19/2019; 02/07/2020; 02/11/2020
• Supplement Dates FDA Received: 12/10/2019; 12/30/2019; 02/07/2020; 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: REBAR¿ 18 MICROCATHETER (MEDTRONIC).