MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X33 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Catalog Number	ET007533
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - 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.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 company is seeking this information through the event investigation.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.
Event or Problem Description
As reported by the field, during a mechanical thrombectomy, embotrap ii 5x33 revascularization device (et007533, 23e251av) became impeded in the distal end of prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not pass through the microcatheter (mc).The physician removed the stent and microcatheter from the patient and switched to a new microcatheter to use delivery of the same embotrap, but it had the same problem.The physician only retracted the stent and switched a new stent (other brand) to complete the surgery.The second microcatheter was not replaced.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this med watch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, during a mechanical thrombectomy, embotrap ii 5x33 revascularization device (et007533, 23e251av) became impeded in the distal end of prowler select plus 150/5cm microcatheter (606s255x, lot unknown) and could not pass through the microcatheter (mc).The physician removed the stent and microcatheter from the patient and switched to a new microcatheter to use delivery of the same embotrap, but it had the same problem.The physician only retracted the stent and switched a new stent (other brand) to complete the surgery.The second microcatheter was not replaced.No additional information is available.The embotrap was found to be encased in foreign matter, once this was removed with water the embotrap returned to its original shape.Examination under magnification of the returned embotrap device showed minor evidence of offset coils and deformation of the distal inner channel.Visual inspection of the remainder of the device indicated no additional damage.The visual inspection indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The returned embotrap device was successfully passed through a 0.0195¿ id tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.The complaint event stated the stent was impeded in the microcatheter and could not pass through.The complaint unit returned stuck in the prowler microcatheter and excessive force was needed to remove the embotrap.The returned prowler was damaged while attempting to remove the embotrap and was unusable afterwards.Device insertion and delivery assessments were performed using the returned embotrap device and a sample prowler microcatheter.The returned embotrap device was able to be fully inserted into the sample prowler microcatheter and delivered to the distal tip without resistance.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.As the embotrap was returned stuck in the microcatheter, the complaint event was confirmed.However, recreation completed with a sample prowler indicated there was no problems associated with the embotrap device.The obstruction may have been the result of foreign matter stuck in the microcatheter, however the root cause for this complaint could not be confirmed with the information provided.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.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.
• 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 ; 3035526892
• MDR Report Key: 20170316
• Report Number: 3011370111-2024-00080
• Device Sequence Number: 7058519
• Product Code: NRY
• UDI-Device Identifier: 10886704081326
• UDI-Public: (01)10886704081326(17)260501(10)23E251AV
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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 Expiration Date: 05/01/2026
• Device Catalogue Number: ET007533
• Device Lot Number: 23E251AV
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 09/16/2024; 10/22/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/16/2024; 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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: PROWLER SELECT PLUS 150/5CM.
• Patient Sex: Unknown