MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP II 5X21 REVASC. DEV.; CATHETER, THROMBUS RETRIEVER

Catalog Number ET007521

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/22/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Initial reporter phone: (b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.Review of the provided photograph shows evidence of deformation present on the distal coil of the embotrap device.This is likely what is referenced in the complaint event description where the ¿stent tip was kinked/bent¿ was observed.No further damage or deformation was observed on the embotrap device in the provided photograph.The cause of the deformation present cannot be determined from the photograph provided.A device history review (dhr) associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The review of the provided photograph confirms the presence of deformation on the distal coil of the embotrap device.The root cause of the reported complaint event cannot be determined from the provided photograph.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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by the field, prior to the mechanical thrombectomy, the physician opened the packaging of an embotrap ii 5x21 revascularization device (et007521, 20j054av) for inspection and observed the stent tip was kinked/bent.A new device was switched to complete the surgery.There was no patient injury reported as the device was not clinically used.The device was stored in the lab and handled per the instructions for use (ifu).There was no damage noted to the packaging.The integrity of the sterile pouch was not compromised.The physician opened the outer packaging and observed the inner packaging was intact.

Manufacturer Narrative

Product complaint #
=
> pc-(b)(4).Updated section on this medwatch report: b4, d9, g3, g6, h2, h3 and h10.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.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by the field, prior to the mechanical thrombectomy, the physician opened the packaging of an embotrap ii 5x21 revascularization device (et007521, 20j054av) for inspection and observed the stent tip was kinked/bent.A new device was switched to complete the surgery.There was no patient injury reported as the device was not clinically used.The device was stored in the lab and handled per the instructions for use (ifu).There was no damage noted to the packaging.The integrity of the sterile pouch was not compromised.The physician opened the outer packaging and observed the inner packaging was intact.The initial examination of the returned embotrap device showed evidence of minor deformation present on the distal coil of the device.No further damage or deformation was observed on any other part of the returned device.The visual inspection also indicates that the returned embotrap device was correctly assembled and manufactured, with all adhesive bonds and joints complete and undamaged.The returned embotrap device in its returned state was successfully passed through a 0.0195¿ id tube, confirming that the profile conformed to the specification for compatibility with 0.021¿ microcatheters.The ptfe insertion tool was dimensionally inspected and found to be within specification for the inner and outer diameter.Device insertion and delivery assessments were performed using the returned embotrap device in its returned state and a sample 0.021¿ microcatheters.The returned embotrap device was successfully delivered to the distal tip of the sample microcatheter without issue.This indicates that the deformation present on the distal coil of the returned embotrap device did not impact the device¿s compatibility with 0.021¿ microcatheters.A device history review (dhr) associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The returned embotrap device shows evidence of minor deformation of the distal coil of the device.No further damage to the remainder of the device was observed.The complaint event description reported that this deformation was present on the device when it was first removed from the device packaging.The returned embotrap device in its returned state was successfully delivered through a sample 0.021¿ microcatheter, indicating that the deformation present on the distal coil of the device had no functional impact to the deliverability of the device.The complaint event description reported that the product was stored and handled as per ifu requirements, no damage was observed on the packaging and that the integrity of the sterile pouch was not compromised.The embotrap device undergoes visual inspection during assembly of the device, both in-process and at final inspection where deformation of this nature would be identified.Additionally, the embotrap device packaging has been shown to sufficiently protect the device during transportation and storage, demonstrated through transportation testing.Based on this and the details reported in the complaint event, the root cause of the deformation present on the distal coil of the device cannot be confirmed.There is no indication that this complaint was a result of a defect or malfunction of the embotrap device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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 5X21 REVASC. DEV.
• 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 ; 3035526892
• MDR Report Key: 16386172
• MDR Text Key: 309673435
• Report Number: 3011370111-2023-00025
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2023

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 Expiration Date: 08/20/2023
• Device Catalogue Number: ET007521
• Device Lot Number: 20J054AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 02/27/2023; 03/27/2023
• Supplement Dates FDA Received: 02/28/2023; 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2020
• 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