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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURAVI LTD. EMBOGUARD 87, 95 CM; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

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NEURAVI LTD. EMBOGUARD 87, 95 CM; CATHETER, PERCUTANEOUS, NEUROVASCULATURE Back to Search Results
Catalog Number BG8795U
Device Problem Deflation Problem (1149)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2023
Event Type  malfunction  
Event Description
The healthcare professional reported that during a thrombectomy procedure to treat a cerebral infarction at the middle cerebral artery (mca), during the device prep, the physician felt that the complaint device, a 95cm emboguard 87 balloon guide catheter (bg8795u / 0000204155) ¿took too much time to remove air.¿ the emboguard could be used with no problem and the procedure was successfully completed.There was no negative impact to the patient.
 
Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: initial reporter phone: (b)(6).The initial reporter email address is not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of the manufacturing documentation associated with this lot (0000204155) 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.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 documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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 failure.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.
 
Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 21-aug-2023.[additional information]: on 21-aug-2023, additional information was received.The information indicated that the only information available is as follows: the surgical access point was femoral.The deflation issue was not encountered after each inflation.Continuous flush was maintained.The reported issue did not result in any clinically significant delay in the procedure.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.
 
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Brand Name
EMBOGUARD 87, 95 CM
Type of Device
CATHETER, PERCUTANEOUS, NEUROVASCULATURE
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 Key17544892
MDR Text Key321189929
Report Number3011370111-2023-00096
Device Sequence Number1
Product Code DQY
UDI-Device Identifier10886704082743
UDI-Public10886704082743
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K212340
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/21/2023
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 Expiration Date03/13/2024
Device Catalogue NumberBG8795U
Device Lot Number0000204155
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/24/2023
Initial Date FDA Received08/14/2023
Supplement Dates Manufacturer Received08/21/2023
Supplement Dates FDA Received08/21/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/14/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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