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

Catalog Number	ET309645
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.A review of the manufacturing documentation associated with this lot: (24g058av) top and sub assembly presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformance's related to device manufacture or inspection.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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 or Problem Description
The healthcare professional reported that during a thrombectomy procedure, when the physician removed the 6.5mm x 45mm embotrap iii revascularization device (et309645 / 24g058av) after he made the first pass, and he noticed that the device ¿may have had some of the coating flaking off.¿ the physician set aside the device and opened a new device to use for the procedure.There was no report of any negative patient impact.On 04-dec-2024, additional information was received.Per the information, the procedure was on (b)(6) 2024.It was targeting the left internal carotid artery (ica) terminus.The clot was a large fibrin rich hyperdense clot.The target vessel had mild to moderate tortuosity.There was no physical damage to the stent / cage assembly.The damage reported was clarified as ¿about 2 cm proximal to the proximal radiopaque 20mm coil¿ flaked off.The concomitant microcatheter used was a phenom¿ 21 microcatheter (medtronic).The replacement device was another 6.5mm x 45mm embotrap iii device (et309645).The information also confirmed there was no negative patient impact and no delay in the procedure as a result of the reported issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 06-jan-2025.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.11.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: the complaint device was received.The examination under magnification of the returned embotrap device showed no evidence of damage or deformation on outer cage, inner channel, distal or proximal coils and bonds.The visual inspection indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.It was reported that after the first thrombectomy pass, the physician noticed the device ¿may have had some of the coating flaking off¿.Visual inspection of the returned embotrap iii showed no evidence of coating flaking.The returned embotrap device could not pass through a 0.0195- inch id tube, due to a buildup of biological matter at 250mm from the distal tip.The polytetrafluoroethylene (ptfe) insertion tool was dimensionally inspected and found to be within specification for the inner and outer diameter.The complaint event was therefore not confirmed.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.A review of the manufacturing documentation associated with this lot (24g058av) 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.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation 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: b.4, g.3, g.6.H.2, h.3, h.6, and h.11.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
• Common Device Name: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 20847977
• Report Number: 3011370111-2024-00111
• Device Sequence Number: 18128277
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: (01)10886704082859(11)240626(17)270626(10)24G058AV
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K211338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/15/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: ET309645
• Device Lot Number: 24G058AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 01/06/2025; 01/15/2025
• Initial Report FDA Received Date: 12/04/2024
• Supplement Report FDA Received Date: 01/06/2025; 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHENOM¿ 21 MICROCATHETER (MEDTRONIC)
• Patient Sex: Unknown