MAUDE Adverse Event Report: NEURAVI LTD. EMBOGUARD 87, 95 CM; EMBOGUARD BALLOON GUIDE CATHETER

Model Number BG8795U

Device Problems Deflation Problem (1149); Deformation Due to Compressive Stress (2889)

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

Event Date 06/24/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # :(b)(4).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

As reported by the field, during a mechanical thrombectomy to the internal carotid artery (ica) for a cerebral infarction, an embotrap iii, embovac intermediate catheter and an emboguard 87, 95 cm balloon guide catheter (bg8795u, lot unknown) were used.Recanalization could not be achieved with standard method.The emboguard was relatively easily to insert to the lesion, but when aspirated from the emboguard, the shaft got crushed due to high thrombus volume.The shaft was flattened when the unspecified microcatheter (mc) was pulled out.Also, deflation was a bit slow and was difficult to remove the air, too.The procedure was completed with implanting unspecified the stents up to ica.There was no negative impact to the patient.A continuous flush was done.

Manufacturer Narrative

Product complaint # (b)(4).Section b5: additional information received indicated that the emboguard used for direct aspiration.The deficiency is only alleged for emboguard.The balloon was deflated.The device was removed intact (in one piece) from the patient.Complaint conclusion: as reported by the field, during a mechanical thrombectomy to the internal carotid artery (ica) for a cerebral infarction, an embotrap iii, embovac intermediate catheter and an emboguard 87, 95 cm balloon guide catheter (bg8795u, lot unknown) were used.Recanalization could not be achieved with standard method.The emboguard was relatively easily to insert to the lesion, but when aspirated from the emboguard, the shaft got crushed due to high thrombus volume.The shaft was flattened when the unspecified microcatheter (mc) was pulled out.Also, deflation was a bit slow and was difficult to remove the air, too.The procedure was completed with implanting unspecified the stents up to ica.There was no negative impact to the patient.A continuous flush was done.Additional information received indicated that the emboguard used for direct aspiration.The deficiency is only alleged for emboguard.The balloon was deflated.The device was removed intact (in one piece) from the patient.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaints could not be confirmed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Per the instructions for use (ifu) the balloon deflation instructions are as follow: a.If using an lav: attach a 20ml syringe to the lav and apply vacuum until the balloon is fully deflated.B.If using a 3 way stopcock: turn the stopcock to allow flow to the 20ml syringe and apply vacuum until balloon is fully deflated.Turn stopcock to prevent flow to balloon.C.Ensure balloon is fully deflated before withdrawing the catheter.Different contrast media to heparinized saline ratios, other than the recommended ratio described, may affect device visibility and may impact the balloon deflation time.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: EMBOGUARD 87, 95 CM
• Type of Device: EMBOGUARD BALLOON GUIDE CATHETER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt; business park; galway H91 K 5YD; EI H91 K5YD
• Manufacturer (Section G): CREGANNA MEDICAL; parkmore west; galway H91 V N2T; EI H91 VN2T
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17315964
• MDR Text Key: 319659544
• Report Number: 3011370111-2023-00084
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10886704082743
• UDI-Public: 10886704082743
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K212340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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 Model Number: BG8795U
• Device Catalogue Number: BG8795U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/27/2023
• Supplement Dates FDA Received: 08/09/2023
• 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: EMBOTRAP III.; EMBOVAC INTERMEDIATE CATHETER.; UNSPECIFIED MICROCATHETER.