MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 5 MM X 37 MM; EMBOTRAP III REVASCULARIZATION DEVICE

Model Number ET309537

Device Problem Material Separation (1562)

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

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Date of event - the date of the event was not reported.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported by a healthcare professional that during a mechanical thrombectomy procedure, the tip of a 5mm x 37mm embotrap iii revascularization device (et309537/21a160av) broke off as the microcatheter (size/brand/manufacturer not specified) was retracted.The physician was able to retrieve the broken tip with a snare and the procedure was completed successfully.Per the reporting physician, the tip of the device may have broken due the mishandling by some of the new technicians that had started in interventional radiology (ir).The device was returned for evaluation.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that during a mechanical thrombectomy procedure, the tip of a 5mm x 37mm embotrap iii revascularization device (et309537/21a160av) broke off as the microcatheter (size/brand/manufacturer not specified) was retracted.The physician was able to retrieve the broken tip with a snare and the procedure was completed successfully.Per the reporting physician, the tip of the device may have broken due the mishandling by some of the new technicians that had started in interventional radiology (ir).The device was returned for evaluation.No further information was provided.The initial examination of the returned embotrap device identified damage to the distal coil and extended strut of the inner channel of the embotrap device.No further damage was noted at any other locations on the device.The visual inspection also indicates that the returned embotrap device was correctly assembled and manufactured, with adhesive bonds and joints present on all areas of the device.There is evidence of welding and adhesive present at the distal joint indicating that the distal joint was correctly bonded prior to the complaint event.The damage noted during the visual inspection under magnification i.E.Unwound and fractured distal coil and distal fracture of the inner channel extended strut are consistent with a material failure under tension.Sem analysis of the appearance of the fracture faces of the distal coil and inner channel extended strut also indicates the fractures are consistent with a material failure under tension.A review of the manufacturing documentation associated with lot 21a160av presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Initial examination of the returned device confirmed the detachment and damage to the device¿s distal tip as reported.The damage present on the distal coil and inner channel extended strut (both components of the distal tip assembly) resulted in fracture and separation of part of the distal coil and the extended strut of the inner channel of the device.All other elements of the design were present and correctly assembled on the returned device.There was evidence of welding and adhesive present on the distal joint of the device, indicating the distal joint was correctly bonded prior to the complaint event.Examination of the fracture sites of the distal coil and inner channel¿s extended strut under high magnification indicated the fracture is consistent with a material failure under tension.There was no evident of a material fault which would result in lower than anticipated tensile load failure.The complaint report suggested the tip damage was due to poor handling by new technicians not familiar with the device.Based on the visual examination of the returned device and the complaint report, the probable cause of the tip damage was a material failure under tension as a result of a uniaxial force applied to the tip, it is possible this occurred during handling.Visual inspection confirmed there was no evidence of damage or deformation to the remainder of the device, indicating that significant (tensile) forces were not applied to the other portions of the device.This suggests that the tensile force that resulted in the tip fracture was localised to the distal tip, this is also consistent with tip fracture due to poor technique when handling the device, such as, for example, pulling the device by the tip.There is no indication that this complaint was as a result of a defect with the embotrap device.Distal tip separation is a known potential procedural complication associated with the use of the embotrap iii device in endovascular mechanical thrombectomy.According to the embotrap iii instructions for use (ifu): "before use inspect the device carefully for damage.Do not use damaged or kinked devices.The device should only be used by physicians trained in neurointerventional catheterization and the treatment of ischemic stroke." with the information provided, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting.This file will be reassessed if additional information becomes available.As part of 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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: EMBOTRAP III 5 MM X 37 MM
• Type of Device: EMBOTRAP III REVASCULARIZATION DEVICE
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; galway H91 K 5YD; EI H91 K5YD
• MDR Report Key: 12555061
• MDR Text Key: 276843410
• Report Number: 3011370111-2021-00117
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704084570
• UDI-Public: 10886704084570
• Combination Product (y/n): N
• PMA/PMN Number: K193063
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: ET309537
• Device Catalogue Number: ET309537
• Device Lot Number: 21A160AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention