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

Model Number BG8795U

Device Problems Deflation Problem (1149); Inflation Problem (1310); Material Twisted/Bent (2981)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The product was received in the product analysis lab on (b)(6) 2022.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.A review of the manufacturing documentation associated with this lot (0000155431) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.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.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 manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that the 95cm emboguard 87 balloon guide catheter (bg8795u / 0000155431) was used in a stroke case, but the balloon could not be inflated in the patient.After the balloon was removed and brought to the back table where the physician inflated it, however, it could not be deflated.The healthcare professional also noted that the kink in the catheter happened as the table was broken down, not during the case.There was no report of any negative patient impact.On (b)(6) 2022, additional information was received.The information indicated that the procedure was on (b)(6) 2022.The surgical access point was femoral.The target vessel was excessively tortuous / with acute bends.The information indicated that it was not known if an introducer sheath was used nor if there was use of a peel-away sheath.The information provided the following on how the procedure was completed: ¿the emboguard was placed but could not reach the desired location in the vasculature.It was removed and replaced with another catheter (not emboguard).The procedure was then completed with the second catheter.The emboguard balloon was not inflated in the patient.On the back table after the procedure was done, the physician inflated the balloon to see how it felt using 60% contrast and 40% saline (ifu says to use 50/50 contrast/saline).The balloon would not deflate, but again, it was not in the patient.It was on the back table.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that the 95cm emboguard 87 balloon guide catheter (bg8795u / 0000155431) was used in a stroke case, but the balloon could not be inflated in the patient.After the balloon was removed and brought to the back table where the physician inflated it, however, it could not be deflated.The healthcare professional also noted that the kink in the catheter happened as the table was broken down, not during the case.There was no report of any negative patient impact.On 21-oct-2022, additional information was received.The information indicated that the procedure was on (b)(6) 2022.The surgical access point was femoral.The target vessel was excessively tortuous / with acute bends.The information indicated that it was not known if an introducer sheath was used nor if there was use of a peel-away sheath.The information provided the following on how the procedure was completed: ¿the emboguard was placed but could not reach the desired location in the vasculature.It was removed and replaced with another catheter (not emboguard).The procedure was then completed with the second catheter.The emboguard balloon was not inflated in the patient.On the back table after the procedure was done, the physician inflated the balloon to see how it felt using 60% contrast and 40% saline (ifu says to use 50/50 contrast/saline).The balloon would not deflate, but again, it was not in the patient.It was on the back table.¿ the complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: the initial examination of the returned emboguard device identified kinking of the shaft at approximately 824mm and 115mm from the distal tip and flattening of the shaft between approximately 93mm and 103mm from the distal tip of the emboguard device.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, with all adhesive bonds and joints complete and undamaged.The returned emboguard device was successfully inflated and deflated using a water/dye solution, confirming that the ability of the balloon to inflate and deflate was not impacted by the kink/flattening present.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 initial kink (824mm from distal tip) as the ball gauge could not be advanced past this point without resistance.Recreation of the kinking was not attempted as the complaint report detailed kinking occurred post procedure during the ¿break down¿ of the back table therefore confirming that the kinks were unrelated to the case.Balloon inflation was not performed during the procedure.The complaint report detailed that the balloon would not deflate after the physician inflated the balloon with 60% contrast and 40% saline on the back table post procedure.Balloon inflation/deflation was attempted on the returned complaint unit and a sample unit using contrast/saline solution (ratio 60:40).The balloon deflated fully on both units within the device deflation time specification, thus the complaint event was not confirmed.Investigation conclusion: the returned emboguard device shows visible damage (kink) at 824mm, and 115mm and (flattening) between 93mm and 103mm 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, kinks present prevented the ball gauge from advancing though the entire bgc main lumen.The complaint report detailed that the catheter kinked post procedure when the back table was being broken down.The presence of kinks was confirmed on the returned device.The kinks did not occur during use of the emboguard device in the procedure.Balloon inflation was not performed during the procedure.It was reported that the balloon would not deflate post procedure on the back table when using a solution of 60% contrast media and 40% saline.Attempted recreation demonstrated that the balloon deflates fully when using contrast/saline (60:40) solution, and within device specifications for deflation time, and therefore the complaint event was not confirmed.The ifu states that the use of contrast media and saline in ratios other than the recommended 50:50 ratio, may affect device visibility and may impact the balloon deflation time.A review of the manufacturing documentation associated with this lot (0000155431) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.There is no indication that this complaint was as a result of a defect or malfunction of the emboguard device.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• 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 ; 303552-689
• MDR Report Key: 15709813
• MDR Text Key: 307577989
• Report Number: 3011370111-2022-00098
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10886704082743
• UDI-Public: 10886704082743
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: BG8795U
• Device Catalogue Number: BG8795U
• Device Lot Number: 0000155431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/15/2022
• Initial Date FDA Received: 11/01/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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