MAUDE Adverse Event Report: NEURAVI LTD. EMBOTRAP III 6.5 MM X 45 MM; CATHETER, THROMBUS RETRIEVER

Catalog Number ET309645

Device Problems Fracture (1260); Retraction Problem (1536)

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

Event Date 04/24/2024

Event Type  malfunction  

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 as indicated as ¿other¿ in this section as the reason for non-evaluation.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 Description

It was reported, via a healthcare professional, that an embotrap iii 6.5 mm x 45 mm (et309645/ 24b092av) was used for a thrombectomy procedure.During the procedure, the user reported strut separation of the embotrap iii device while in patient.The fragment was captured within and retrieved through the base catheter.The procedure was successfully completed and there was no injury to the patient.The event resulted in a five-minute delay, during which the device and fragment was being removed from the patient.There was no patient consequence.The event was reported as such, ¿distal tip of embotrap iii 6.5 x 45 fractured off in patient.Fragment was captured within and retrieved through base catheter.No injury to patient.Was surgery delayed due to the reported event? ¿yes.¿ if yes, number of minutes: ¿5.¿ action taken when event occurred? ¿device removed.Fragments retrieved.¿ was procedure successfully completed? ¿yes.¿ were fragments generated? ¿yes.¿ if yes, were they removed easily without additional intervention? ¿yes.¿ patient status/ outcome / consequences? ¿no.¿ was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: ¿no.¿.No further information was made available at the time of this review.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional event information received on 29-apr-2024 indicated that no excessive force was been applied to the device.The system was used with the recommended microcatheter.One pass had been made to attempt to retrieve the clot when the event occurred.The device was not torqued or rotated during advancement.The damage occurred after the device was deployed.There was difficulty withdrawing the device into a zoom 88 aspiration catheter.The procedure was delayed by 5 minutes due to the event; the delay was not clinically significant.Based on the additional event information received the medical device problem code, retraction problem, has been added to this report.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).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: it was reported, via a healthcare professional, that an embotrap iii 6.5 mm x 45 mm (et309645/ 24b092av) was used for a thrombectomy procedure.During the procedure, the user reported strut separation of the embotrap iii device while in patient.The fragment was captured within and retrieved through the base catheter.The procedure was successfully completed and there was no injury to the patient.The event resulted in a five-minute delay, during which the device and fragment was being removed from the patient.There was no patient consequence.The event was reported as such, ¿distal tip of embotrap iii 6.5 x 45 fractured off in patient.Fragment was captured within and retrieved through base catheter.No injury to patient.Was surgery delayed due to the reported event? ¿yes.¿ if yes, number of minutes: ¿5.¿ action taken when event occurred? ¿device removed.Fragments retrieved.¿ was procedure successfully completed? ¿yes.¿ were fragments generated? ¿yes.¿ if yes, were they removed easily without additional intervention? ¿yes.¿ patient status/ outcome / consequences? ¿no.¿ was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: ¿no.¿ additional event information received on 29-apr-2024 indicated that no excessive force was been applied to the device.The system was used with the recommended microcatheter.One pass had been made to attempt to retrieve the clot when the event occurred.The device was not torqued or rotated during advancement.The damage occurred after the device was deployed.There was difficulty withdrawing the device.The procedure was delayed by 5 minutes due to the event; the delay was not clinically significant.The initial examination of the returned embotrap iii device identified a missing distal coil and damage to the extended strut of the inner channel of the embotrap iii device.The visual inspection indicates that a marker at the distal segment of the device is missing, and no further damage was noted at any other locations on the device.The visual inspection also indicates that the returned embotrap iii 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 fracture of the inner channel extended strut noted during the visual inspection under magnification is consistent with a material failure under tension.Recreation attempts of the extended strut fracture were performed in the e062-02 silicone vascular model using a sample embotrap iii device and a sample prowler select plus microcatheter.Despite repeated attempts, the distal coil did not fracture, however deformation to the distal coil was observed.Conclusion: initial examination of the returned device confirmed the fracture of the extended strut distal tip of the device as reported.Therefore, the complaint event is confirmed.The damage present on inner channel extended strut resulted in fracture of the extended strut and loss of the distal coil.In addition, a missing marker on the distal end of the returned device was noted.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 site of the inner channel¿s extended strut under high magnification indicated the fracture is consistent with a material failure under tension.There was no evidence of a material fault which would result in a lower than anticipated tensile load failure.Based on the visual examination of the returned device, the probable cause of the tip damage was a material failure under tension as a result of a uniaxial force applied to the tip.Potential cause of the damage is interaction of the embotrap iii device with a microcatheter/accessory or due to device handling.Recreation attempts of embotrap iii distal tip fracture were performed on a sample embotrap iii device.Minor deformation to the distal coil was caused by repeated deployments at a vessel wall.It was concluded that minor damage to the distal coil through deployment against the vessel wall may lead to device entanglement.Whilst the complaint event is confirmed, the root cause could not be determined.There is no indication that this complaint was as a result of a defect with the embotrap iii device.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 III 6.5 MM X 45 MM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; 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: 19201848
• MDR Text Key: 341738674
• Report Number: 3011370111-2024-00033
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 10886704082859
• UDI-Public: 10886704082859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ET309645
• Device Lot Number: 24B092AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 04/29/2024; Not provided
• Supplement Dates FDA Received: 05/08/2024; 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/07/2024
• 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: ZOOM 88 ASPIRATION CATHETER
• Patient Sex: Female