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

Model Number	BG8785U
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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.
Event or Problem Description
As reported by a sales representative, an emboguard 87, 85 cm balloon guide catheter (bg8785u, 0000155432) was prepped outside the patient.The balloon was inflated and tested before introduced into patient.After the emboguard (eg) was placed, the physician attempted to inflate the balloon and he noticed the contrast escaping the balloon under x-ray.The physician used the eg either way to finish case with no complaint.There were no surgery delays due to the reported event and the procedure was successfully completed.Additional information received indicated that an 8f 11cm sheath was used.Balloon was inflated using lav.A 1ml syringe was used to gently infuse contrast material in balloon.The leak was located on the balloon itself.The device did not appear to be kinked or damaged in any way.There was no evidence of air being injected into patient.Treatment was to the right middle cerebral artery (rmca) with mild tortuosity.
Additional Manufacturer Narrative
Product complaint #(b)(4).Complaint conclusion: as reported by a sales representative, an emboguard 87, 85 cm balloon guide catheter (bg8785u, 0000155432) was prepped outside the patient.The balloon was inflated and tested before introduced into patient.After the emboguard (eg) was placed, the physician attempted to inflate the balloon and he noticed the contrast escaping the balloon under x-ray.The physician used the eg either way to finish case with no complaint.There was no surgery delays due to the reported event and the procedure was successfully completed.Additional information received indicated that an 8f 11cm sheath was used.Balloon was inflated using lav.A 1ml syringe was used to gently infuse contrast material in balloon.The leak was located on the balloon itself.The device did not appear to be kinked or damaged in any way.There was no evidence of air being injected into patient.Treatment was to the right middle cerebral artery (rmca) with mild tortuosity.The initial examination of the returned emboguard device identified balloon material removed from the catheter shaft and minor shaft flattening between approximately 65mm and 73mm from the distal tip of the emboguard device.No further damage was noted at any other locations on the device.The returned emboguard device could not be inflated as the balloon material was not attached to the 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 as the ball gauge could not be advanced past this point without resistance.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The returned emboguard device shows visible damage to the balloon and flattening between 65mm and 73mm from the tip.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, minor flattening present prevented the ball gauge from advancing though the entire bgc main lumen without resistance.The complaint report detailed that there was a leak on the balloon during the procedure, however the unit was returned with no balloon attached to the device.Therefore the complaint event was not confirmed.Root cause of the balloon leak could not be determined due to insufficient information provided (i.E.Device position, ancillary devices used) and due to the absence of the balloon on the returned emboguard bgc.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: EMBOGUARD 87, 85 CM
• Common Device Name: EMBOGUARD BALLOON GUIDE CATHETER
• Manufacturer (Section D): NEURAVI LTD.; block 3 ballybritt business pa; 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: 15615196
• Report Number: 3011370111-2022-00097
• Device Sequence Number: 12748020
• Product Code: DQY
• UDI-Device Identifier: 10886704082736
• UDI-Public: 10886704082736
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/14/2023
• Device Model Number: BG8785U
• Device Catalogue Number: BG8785U
• Device Lot Number: 0000155432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1ML SYRINGE; 8F 11CM SHEATH
• Patient Age: 89 YR
• Patient Sex: Male