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); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vasoconstriction (2126); Perforation of Vessels (2135); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: pc-(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Date of event: the date of the event is not known.The expiration date of the device is not known as the device lot number is not available / not reported.Information related to initial reporter facility name, address, the initial report name, phone and email address are not available.The device manufacture date is not known as the device lot number is not available / not reported.[conclusion]: a j&j employee reported that the data was received from a ¿confidential source¿ that a vessel dissection or perforation had occurred due to the 95cm emboguard 87 balloon guide catheter (bg8795u / lot# unknown).Per the data received, the following device issues were encountered: 1.Not being able to deliver devices without technical complications related to the balloon.2.Difficulty in tracking the device through the 8fr guide sheath.3.Emboguard did not inflate or deflate as expected.It was mentioned in the complaint that these issues were likely all from the same case ¿but do not know for certain¿.There was also no mention of what specific ¿technical complications¿ have occurred in relation to the balloon.No other additional information was available.This complaint was discussed with the medical safety officer (mso) and some key members of the cerenovus team on (b)(6) 2022.Given that the mso had been in touch with a clinical team member involved in a study using this device, the assumption in this case is that the vessel dissection/ perforation event happened in one case and is related to the same device rather than different devices.Based on all the device issues relayed, there might have been an issue with the balloon in relation to the encountered difficulty in tracking through the sheath.More likely, the balloon did not inflate or deflate at the level the treating physician wanted it to be.The balloon may have been left deflated and was not stable in position during the retraction or manipulation with the other non-emboguard devices being used in the procedure.Hence, the emboguard may have lost its position and advanced forward causing a vessel dissection/perforation.Unfortunately, no additional or follow up information can be obtained at this time due to the limited access of the clinical study team.If there will be a similar/ duplicate complaint that will come later, further investigation/ follow up will be performed.Based on complaint information, the device is not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue related to the product performance cannot be confirmed.The lot number of the device is not known, therefore review of the device history record was not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported device issues.Vessel dissection/ perforation is a known complication associated with the use of the emboguard device and is mentioned in the instructions for use (ifu) as such.Interference or friction between devices is a known occurrence.If resistance is encountered with the emboguard system, it is advised that it should be withdrawn together as one unit to prevent injury.This is a common practice during procedures and is stated in the product¿s ifu.Failure in balloon inflation as expected indicates evidence of a product malfunction, as the device failed to meet its performance specification or did not perform as intended.Though, such failure has remote potential of causing or contributing to a death or serious injury, or other significant adverse event.In contrast, any difficulty on deflating the balloon can result in temporary reduction in blood flow which can result in ischemia or infarct whether it is a partial/slow deflation or inability to deflate regardless of the timing.The extent of failure in balloon deflation would dictate the severity in the patient¿s health consequence based on the location of the restricted blood flow.As discussed with the mso, there is a direct causal relationship between the emboguard device and the reported event for this complaint.Therefore, the event will be reported to the fda with the classification of ¿serious injury.¿ 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.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

A j&j employee reported that the data was received from a ¿confidential source¿ that a vessel dissection or perforation had occurred due to the 95cm emboguard 87 balloon guide catheter (bg8795u / lot# unknown).Per the data received, the following device issues were encountered: 1.Not being able to deliver devices without technical complications related to the balloon.2.Difficulty in tracking the device through the 8fr guide sheath.3.Emboguard did not inflate or deflate as expected.It was mentioned in the complaint that these issues were likely all from the same case ¿but do not know for certain¿.There was also no mention of what specific ¿technical complications¿ have occurred in relation to the balloon.No other additional information was available.This complaint was discussed with the medical safety officer (mso) and some key members of the cerenovus team on (b)(6) 2022.Given that the mso had been in touch with a clinical team member involved in a study using this device, the assumption in this case is that the vessel dissection/ perforation event happened in one case and is related to the same device rather than different devices.Based on all the device issues relayed, there might have been an issue with the balloon in relation to the encountered difficulty in tracking through the sheath.More likely, the balloon did not inflate or deflate at the level the treating physician wanted it to be.The balloon may have been left deflated and was not stable in position during the retraction or manipulation with the other non-emboguard devices being used in the procedure.Hence, the emboguard may have lost its position and advanced forward causing a vessel dissection/perforation.Unfortunately, no additional or follow up information can be obtained at this time due to the limited access of the clinical study team.If there will be a similar/ duplicate complaint that will come later, further investigation/ follow up will be performed.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the modified information received on 20-oct-2022.[additional information]: on 20-oct-2022, modified information was received by the j&j employee via email.The information is as follows: ¿i had incorrectly understood the vessel injury (perforation or dissection) to be to the intracranial vessel being treated.I have received further clarification that the vessel dissection was actually a radial artery access injury.With regard to whether the emboguard device ¿caused¿ the radial artery injury, per the physician at the site: the initial sheath that was placed was a 6fr slender, which has a smaller od than the emboguard, so the emboguard was the largest device which we put in.The issue was primarily upon removing the emboguard, which was when the radial artery (just below the antecubital fossa) went into severe spasm, resulting in dissection and arterial injury upon removal of the emboguard.¿ there is no further information available.Based on the modified information provided on 20-oct-2022: it was the physician¿s discretion to use the radial artery as the vascular access for the emboguard device which is what the device is intended to do per its ifu.Hence, the resulting event of vascular injury is considered a reasonable complication from the use of the emboguard device.Vessel dissection/perforation and vessel spasm are potential complications associated with the use of the emboguard catheter and are listed as such in the ifu.Therefore, the reportability of this event remains to be mdr reportable.Updated sections: b.4, g.3, g.6, h.2, h.6, and h.10.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15566171
• MDR Text Key: 301477824
• Report Number: 3011370111-2022-00095
• 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: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/21/2022
• 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
• Patient Outcome(s): Life Threatening