MAUDE Adverse Event Report: NEURAVI LTD. ET007533; CATHETER, THROMBUS RETRIEVER

Catalog Number ET007533

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Date of event: the event occurred in june 2021; however, the date of the event was not reported.The name, phone and email address of the initial reporter are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: the healthcare professional reported that the 5mm x 33mm embotrap ii revascularization device (et007533 / lot# unknown) was getting stuck on clot retrieval in the right m1 segment-ica (internal carotid artery) junction.It was reported that the physician was able to withdraw the embotrap device.There was no report of any patient adverse event or patient complication associated with the reported issue.Additional information was received on 09 july 2021.The information indicated that the event occurred in (b)(6) 2021.The clot was described as ¿friable, white, could be described as fat or a cottage-cheese like.¿ the additional information provided the following sequence of events that led up to the reported withdrawal difficulty: the standard set up has been deployed.Initially 2 passes with aspiration have been attempted with no success, therefore the clinician proceeded with co-aspiration using embotrap ii, velocity® delivery microcatheter (penumbra), ace¿ 68 reperfusion catheter (penumbra), neuron max® 088 sheath (penumbra) / select catheter neuron® intracranial access system (penumbra).During first pass with embotrap ii there was no difficulty, but as the results have not been satisfactory, the clinician decided to proceed with another pass with embotrap ii during which on withdrawal the embotrap ii has gotten ¿stuck¿ in the m1/ica junction.Attempts to advance microcatheter has not been successful, therefore the microcatheter has been removed and ace 68 has been advanced over the embotrap ii, which helped to eventually remove the embotrap ii.Suction on ace 68 has been stopped to release the pressure.Two aspiration and 1 pass with the embotrap ii device was made prior to the withdrawal difficulty was encountered, which was the second pass with the same embotrap ii device.There were no difficulties observed in the previous passes.Continuous flush had been maintained through the catheter; standard procedure has been followed.The embotrap ii and the rest of the set up were fully retrieved; there was no sign of damage observed on the embotrap ii device.The reported issue resulted in an approximately two-minute delay that was not significant.The patient has been reported to feel uncomfortable, but there has been no harm sustained to the patient.It was reported that the occlusion was not cleared, but it is a query patient condition as a reason and not necessarily due to the performance of the device.The patient is under medical investigation in relation to blood clotting.It was reported that the embotrap ii device is not available to be returned for evaluation and analysis.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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.In addition, without a lot number to conduct a device history record review, it is not possible to determine if the reported failure could be related to the manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 the 5mm x 33mm embotrap ii revascularization device (et007533 / lot# unknown) was getting stuck on clot retrieval in the right m1 segment-ica (internal carotid artery) junction.It was reported that the physician was able to withdraw the embotrap device.There was no report of any patient adverse event or patient complication associated with the reported issue.Additional information was received on 09 july 2021.The information indicated that the event occurred in (b)(6) 2021.The clot was described as ¿friable, white, could be described as fat or a cottage-cheese like.¿ the additional information provided the following sequence of events that led up to the reported withdrawal difficulty: the standard set up has been deployed.Initially 2 passes with aspiration have been attempted with no success, therefore the clinician proceeded with co-aspiration using embotrap ii, velocity® delivery microcatheter (penumbra), ace¿ 68 reperfusion catheter (penumbra), neuron max® 088 sheath (penumbra) / select catheter neuron® intracranial access system (penumbra).During first pass with embotrap ii there was no difficulty, but as the results have not been satisfactory, the clinician decided to proceed with another pass with embotrap ii during which on withdrawal the embotrap ii has gotten ¿stuck¿ in the m1/ica junction.Attempts to advance microcatheter has not been successful, therefore the microcatheter has been removed and ace 68 has been advanced over the embotrap ii, which helped to eventually remove the embotrap ii.Suction on ace 68 has been stopped to release the pressure.Two aspiration and 1 pass with the embotrap ii device was made prior to the withdrawal difficulty was encountered, which was the second pass with the same embotrap ii device.There were no difficulties observed in the previous passes.Continuous flush had been maintained through the catheter; standard procedure has been followed.The embotrap ii and the rest of the set up were fully retrieved; there was no sign of damage observed on the embotrap ii device.The reported issue resulted in an approximately two-minute delay that was not significant.The patient has been reported to feel uncomfortable, but there has been no harm sustained to the patient.It was reported that the occlusion was not cleared, but it is a query patient condition as a reason and not necessarily due to the performance of the device.The patient is under medical investigation in relation to blood clotting.It was reported that the embotrap ii device is not available to be returned for evaluation and analysis.

• Brand Name: ET007533
• 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 dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12193705
• MDR Text Key: 266733479
• Report Number: 3011370111-2021-00052
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 07/01/2021

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 Catalogue Number: ET007533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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