MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; CATHETER, THROMBUS RETRIEVER

Model Number ET309645

Device Problems Difficult to Remove (1528); Retraction Problem (1536)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device is not known.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 during a thrombectomy procedure targeting an internal carotid artery (ica) occlusion, the issue occurred when the physician attempted to perform the procedure with the 132cm embovac 71 aspiration catheter (ic71132ca / 30594714) and the embotrap revascularization device (catalog and lot# unknown) with the combined technique.The embovac and embotrap were used in accordance with the instructions for use (ifu).It was reported that there was a portion of the ica that was suspected to be stenosed.The microcatheter (unspecified brand) was regionally cross there and the embovac was also regionally crossed following the microcatheter.When the embotrap device was deployed from the microcatheter and drawn into the embovac, there was resistance felt.The drawn-in to the embovac was half completed.The embotrap device was stuck, not able to be pulled nor pushed.The physician commented that the embotrap device was probably caught in the stenosis and trapped.The embotrap device was carefully resheathed into the microcatheter and removed from the patient¿s body.When the embovac was removed, it appeared to be stretched at about 5cm from the tip and was no longer usable.It was replaced with a competitor product and the replacement was used without any problem.The procedure was completed.It was not known if a continuous flush was maintained.There was no patient adverse event or complication reported.Based on complaint information, the device is 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 limited information available and without the product available for analysis, the reported customer complaint could not be confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.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 guide/intermediate catheter, 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.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 during a thrombectomy procedure targeting an internal carotid artery (ica) occlusion, the issue occurred when the physician attempted to perform the procedure with the 132cm embovac 71 aspiration catheter (ic71132ca / 30594714) and the embotrap revascularization device (catalog and lot# unknown) with the combined technique.The embovac and embotrap were used in accordance with the instructions for use (ifu).It was reported that there was a portion of the ica that was suspected to be stenosed.The microcatheter (unspecified brand) was regionally cross there and the embovac was also regionally crossed following the microcatheter.When the embotrap device was deployed from the microcatheter and drawn into the embovac, there was resistance felt.The drawn-in to the embovac was half completed.The embotrap device was stuck, not able to be pulled nor pushed.The physician commented that the embotrap device was probably caught in the stenosis and trapped.The embotrap device was carefully resheathed into the microcatheter and removed from the patient¿s body.When the embovac was removed, it appeared to be stretched at about 5cm from the tip and was no longer usable.It was replaced with a competitor product and the replacement was used without any problem.The procedure was completed.It was not known if a continuous flush was maintained.There was no patient adverse event or complication reported.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 25-aug-2022.E.1: initial reporter phone: (b)(6).[additional information]: on 25-aug-2022, additional event information was received, the information indicated that the embotrap device used was a 6.5mm x 45mm embotrap iii revascularization device (et309645 / 21m022av).There were no damages on the embotrap iii device.Information related to clot characteristics, concomitant microcatheter used, and whether an adequate and continuous flush was maintained could not be obtained.The patient¿s pre- and post-procedure tici scores were also unknown.The information indicated that the withdrawal difficulty issue related to the embotrap iii was withdrawal difficulty into the vessel.The embotrap iii and the embovac were replaced; a competitor stent retriever was used for the second pass.A solitaire¿ stent retriever (medtronic) and a react¿ catheter (medtronic) were used as replacement devices to complete the procedure.It was not known if there was a clinically significant delay in the procedure as a result of the reported issue.A review of the device history records (dhr) confirms that there were no issues with the assembly of the lot 21m022av (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.Updated sections: b.4, d.1, d.4, e.1, e.3, g.3, g.4, g.6, h.2, h.4, 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.

• Brand Name: EMBOTRAP III 6.5 MM X 45 MM
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14893448
• MDR Text Key: 303346857
• Report Number: 3011370111-2022-00065
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: 10886704082859
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

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 Model Number: ET309645
• Device Catalogue Number: ET309645
• Device Lot Number: 21M022AV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/01/2022
• Supplement Dates Manufacturer Received: 08/25/2022
• Supplement Dates FDA Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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
• Treatment: 132CM EMBOVAC 71 ASP. CATHETER