MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; CATHETER, THROMBUS RETRIEVER

Catalog Number ET307537

Device Problem Fracture (1260)

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

Event Date 09/29/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Section d.4: the expiration date of the device is not known as the device lot number is not available / not reported.Section e.1: the initial reporter phone is not available / reported.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.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 complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review 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 may have contributed to the reported failure.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 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 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 the 84-year-old female patient suffered a stroke within several territories: carotid t, left a1/a2, right a1/a2 of the anterior cerebral artery, and the p2 segment of the posterior communicating artery underwent a mechanical thrombectomy procedure.The procedure set-up is as follows: cerebase da guide sheath (catalog / lot# unknown), sofia¿ 6f aspiration catheter (microvention), rebar¿ microcatheter (medtronic), and 5mm x 37mm embotrap iii revascularization device (et307537 / lot# unknown).It was reported that ¿after the sixth thrombectomy with the embotrap iii in [the] p2, the embotrap was torn off and stayed in the vessel.¿ no further information was available at the time of the complaint review.

• Brand Name: EMBOTRAP III 5 MM X 37 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18332359
• MDR Text Key: 330978408
• Report Number: 3011370111-2023-00199
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 12/14/2023

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: ET307537
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/14/2023
• 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
• Treatment: REBAR¿ MICROCATHETER (MEDTRONIC).; SOFIA¿ 6F ASPIRATION CATHETER (MICROVENTION).; UNKNOWN CEREBASE
• Patient Age: 84 YR
• Patient Sex: Female