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 03/05/2020

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 inner channel and outer cage of the device were kinked, meeting regulatory reporting criteria.Date of event: the event occurred on the (b)(4) 2020; however, the month of the event was not reported.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 a healthcare professional, during a thrombectomy procedure, the physician tried to introduce a 5x33 embotrap ii revascularization device (et007533, 19l130av) 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 consequence to the patient.The surgery was delayed by five minutes due to the event.The procedure was successfully completed by using a competitor¿s stent retriever with the same mc.Additional information was received and indicated that the mc did not seem to be damaged.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 with the left hand the doctors holds the y valve and with the right hand he holds the insertion tool and pushes the wire of the device forward.The device was flushed without difficulties.The device was inadvertently deployed in the microcatheter hub to the resistance.There was no loss of cerebral target position because it was not even possible to bring the embotrap inside the mc, so they decided to use another stent retriever.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 outer diameter (od) and inner diameter (id).The returned headway 21 was also inspected, there was no damage noted on the exterior of the catheter and the inner lumen was clear of obstruction.Delivery assessments were completed using a previously unused embotrap ii device in both the returned headway 21 and a new headway 21 microcatheter to note if there were any differences.The same result was observed in both microcatheters, demonstrating there was no permanent deformation present in the returned headway 21 microcatheter.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 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 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 when fully seated.This indicates that there was no defect with the hub of the returned microcatheter as the damaged device delivered successfully.Delivery failed at 5mm due to the damage on the device.A new embotrap was then advanced with no noted resistance and successfully delivered through the entire length of the microcatheter.Advancement was unsuccessful at a gap greater than 14mm, i.E.Incorrectly seated.This was also repeated with a previously unused microcatheter also with the same outcome.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.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 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 19l130av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.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 completed and nothing was found to suggest any defect, 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 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.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 a healthcare professional, during a thrombectomy procedure, the physician tried to introduce a 5x33 embotrap ii revascularization device (et007533, 19l130av) 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 consequence to the patient.The surgery was delayed by five minutes due to the event.The procedure was successfully completed by using a competitor¿s stent retriever with the same mc.Additional information was received and indicated that the mc did not seem to be damaged.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 with the left hand the doctors holds the y valve and with the right hand he holds the insertion tool and pushes the wire of the device forward.The device was flushed without difficulties.The device was inadvertently deployed in the microcatheter hub to the resistance.There was no loss of cerebral target position because it was not even possible to bring the embotrap inside the mc, so they decided to use another stent retriever.Based on the device analysis, the inner channel and outer cage of the device was kinked.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• 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
• MDR Report Key: 10032300
• MDR Text Key: 240398142
• Report Number: 3011370111-2020-00040
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2022
• Device Catalogue Number: ET007533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEADWAY 21 MICROCATHETER