MAUDE Adverse Event Report: NEURAVI LTD. EMBOGUARD 87, 85 CM; EMBOGUARD BALLOON GUIDE CATHETER

Model Number BG8785U

Device Problem Defective Component (2292)

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

Event Date 07/18/2022

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.There was balloon leakage on the device received, meeting regulatory reporting criteria.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 4.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.Complaint conclusion: as reported by the field, ab emboguard balloon guide catheter 87, 85 cm (bg8785u, lot unknown) was prepped prior to use per the technician.After physician use, balloon was noted to have a defect in filling.The balloon has a pimple on the balloon that fills upon balloon inflation.There was no patient injury reported.Additional information received indicated that the surgical access point was the femoral artery.An introducer sheath was not used.There was no use of peel-away sheath.A dilator was used.The balloon did not burst at the site of the "pimple".The case was completed with the same emboguard.There were no procedural delays due to the event.It was confirmed that the issue occurred after use in the patient.The review of the provided photograph indicates there is a defect within the distal balloon bond, resulting in filling of the balloon material within the distal balloon bond during balloon inflation.There was no evidence of further damage or defects present on the bgc in the provided photograph.The root cause of this complaint event cannot be confirmed from the provided photographs.The lot number is not known; therefore, a device history record review cannot be completed.The initial examination of the returned emboguard device identified flattening of the shaft in the balloon region (approx.5mm from distal tip) and at approximately 97mm from the distal tip, minor shaft flattening at approximately 142mm from the tip, and a distal balloon bond defect (raised balloon material).No further damage was noted at any other locations on the device.The visual inspection also indicates that the returned emboguard device was correctly assembled and manufactured.The returned emboguard device was successfully inflated and deflated as per the procedural steps in the instructions for use (ifu), confirming that the ability of the balloon to inflate and deflate was not impacted by the flattening/balloon bond defect present.Upon inflating the balloon, inflation media flowed from the balloon working area into the distal balloon bond via the area of the raised balloon material (¿pimple¿).The ¿pimple¿ as detailed in the complaint event was confirmed to be present on the returned device.A minimum id check of the emboguard device confirmed that there was a restriction in the main lumen of the device at the location of the minor shaft flattening (142mm from distal tip) as the ball gauge could not be advanced past this point without resistance.The emboguard device was advanced into the right ica in an anatomical model and balloon inflation/deflation was successfully completed.In this setup a guidewire and dilator could be advanced through the entire main lumen of the embogurad bgc.Attempted recreation on a sample unit with manipulation of the balloon applied showed that the balloon inflated correctly, and a ¿pimple¿ defect could not be formed.The ifu recommends that the emboguard bgc should be inserted into the selected vessel via an introducer sheath as it acts as a conduit for the bgc and helps prevent damage to the device.The complaint event description reported that the device was delivered without an introducer sheath via the femoral artery.Recreation of this event could not be attempted as the anatomically representative model used in benchtop testing is not made from biological material that represents a vessel wall to simulate the interaction of the emboguard bgc being inserted directly into the femoral artery.In this case it is not possible to replicate the insertion of the bgc without an introducer sheath.The root cause of the complaint event could not be determined.The returned emboguard device shows visible flattening damage at the balloon region.This flattening may have occurred during demonstration of the pimple post the complaint event.Visible damage (flattening) at 97mm from the distal tip and (minor flattening) at 142mm from the tip was present.A defect of the distal balloon bond was also observed on the returned unit.The emboguard device shows no sign of other damage or deformation as a result of the complaint event.The returned emboguard device did not pass a minimum id check using a ball gauge, as the flattening present prevented the ball gauge from advancing though the entire bgc main lumen.The returned emboguard device was successfully inflated and deflated in a straight configuration and in an anatomical model confirming balloon inflation/deflation was not impacted by the flattening/balloon bond defect present.The complaint report detailed that there was a ¿pimple¿ on the balloon that fills upon balloon inflation.Inspection of the returned unit confirmed there was a defect of the distal balloon bond as inflation media flowed from the balloon working area into the bond during inflation.The ifu recommends that the emboguard bgc should be inserted into the selected vessel via an introducer sheath as it acts as a conduit for the bgc and helps prevent damage to the device.The complaint event description reported that the device was delivered without an introducer sheath.While there is potential the distal bond was damaged during sheathless insertion, the root cause of the complaint event could not be determined.There is no indication that this complaint was as a result of a defect or malfunction of the emboguard 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.

Event Description

As reported by the field, ab emboguard balloon guide catheter 87, 85 cm (bg8785u, lot unknown) was prepped prior to use per the technician.After physician use, balloon was noted to have a defect in filling.The balloon has a pimple on the balloon that fills upon balloon inflation.There was no patient injury reported.Additional information received indicated that the surgical access point was the femoral artery.An introducer sheath was not used.There was no use of peel-away sheath.A dilator was used.The balloon did not burst at the site of the "pimple".The case was completed with the same emboguard.There were no procedural delays due to the event.It was confirmed that the issue occurred after use in the patient.Based on the analysis of the device received, a balloon leakage was noted.

• Brand Name: EMBOGUARD 87, 85 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15362303
• MDR Text Key: 305809890
• Report Number: 3011370111-2022-00086
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10886704082736
• UDI-Public: 10886704082736
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BG8785U
• Device Catalogue Number: BG8785U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2022
• Date Manufacturer Received: 09/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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