MAUDE Adverse Event Report: CERENOVUS, INC. CEREGLIDE; CATHETER, PERCUTANEOUS, NEUROVASCULATURE

Catalog Number	SBC92122UG
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	Vasoconstriction (2126); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter email address was not available / reported.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (31472255) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Vasospasm is a known potential complication associated with the use of the cereglide92 intermediate catheter and is listed in the instructions for use (ifu) as such.A vasospasm is a temporary tightening of the muscles in the vessel wall.This can narrow and briefly decrease or even prevent blood flow distal to the spasm and may occur when positioning/advancing the devices through the vessel/arteries.It was also reported that the catheter (body/shaft) was found to be compressed/crushed when removed from the patient; this was likely related to the vasospasm, which exerted pressure on the catheter.Since the device was in use at the time of the vasospasm, the relationship between the event and the used device as a contributing factor cannot be ruled out entirely.Additionally, the event required intravenous medicinal treatment.Based on this information, this event meets us fda reporting criteria under 21 cfr 803 with the classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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 or Problem Description
The healthcare professional reported that during a thrombectomy procedure to treat a right m2 ischemic stroke, access was made via the right femoral artery using an 8f 90cm flexor® shuttle® guiding sheath (cook medical) placed into the proximal right internal carotid artery (ica).A cereglide 92 innerglide 9 122 cm catheter system (sbc92122ug / 31472255) was brought up with an aristotle® 24 guidewire (scientia vascular).The aristotle guidewire and the cereglide 92 inner glide 9 was brought up to proximal to face the clot at the m1/m2 bifurcation.The cereglide 92 was brought up over the inner glide 9 to face the clot.Manual aspiration was applied to the cereglide 92.The cereglide 92 was then brought back to distal ica.The vaclok® vacuum pressure syringe (merit medical) was removed and no clot was seen in the discard / aspirate of the alok.Manual contrast injection through the cereglide 92 showed a tici score of 2b with blood flow restored.There were still clot in the right m2 segment; the physician went back up with the inner glide 9 and the aristotle guidewire to face the clot in the m2, the cereglide 92 was tracked over.Manual aspiration was applied to the cereglide 92.The cereglide 92 was brought back to the distal ica.Vaclok syringe was removed.Fibrin rich clot with red blood cell (rbc) rich clot was seen in the discard / aspirate from the vaclok.Manual contrast injection through the cereglide 92 showed a tici score of 2c.A slight spasm was reported in the m2 and verapimil was given.Final injection showed that the spasm has improved.As the physician was taking the cereglide 92 around a curve, the shuttle sheath rode up on the cereglide 92.When it was removed from the patient, there was a flattened portion of the catheter in the mid-distal end.The physician believes that due to the softness of the catheter, ¿it collapsed around the bend of the vessel and the distal tip of the shuttle creating the flattened portion.¿ the procedure was reported as successfully completed without any delay.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional information received on 05-dec-2024 and on 10-dec-2024.[additional information]: on 05-dec-2024, additional information was received.Per the information, the vasospasm resolved after verapamil was given.The dosage of the verapamil is not available.The physician did not believe that the softness of the catheter which collapsed around the bend of the vessel resulted in the vasospasm.The ¿vasospasm was in m2, bend occurred during the removal in the ica.¿ per the information, the ica was tortuous with a few bends.Information related to whether the patient¿s hospitalization was prolonged is not available.On 10-dec-2024, additional information was received.Per the information, "the vasospasm was in m2 post thrombectomy.The distal tip of cg92 was in the distal m1 when it was seen.The area of damage in cg92 was not around the vasospasm at all." per the additional information received on 10-dec-2024, the vasospasm occurred ¿post thrombectomy.¿ based on this information, the correlation between the event to the used device can be ruled out.Therefore, the reported vasospasm no longer meets us fda reporting criteria.The file will be re-reviewed if additional information is received at a later date.The reportability of the file was also reassessed.Based on the information provided, the event no longer meets no longer meets usfda medical device reporting criteria.Updated sections: b.4, g.3, g.6, h.2, h.6, and h.11.

• Brand Name: CEREGLIDE
• Common Device Name: CATHETER, PERCUTANEOUS, NEUROVASCULATURE
• Manufacturer (Section D): CERENOVUS, INC.; 6303 waterford district drive; suites 215 & 315; miami FL 33126
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 20822501
• Report Number: 3007628272-2024-00063
• Device Sequence Number: 12725366
• Product Code: QJP
• UDI-Device Identifier: 10886704086048
• UDI-Public: (01)10886704086048(11)241003(17)270930(10)31472255
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: SBC92122UG
• Device Lot Number: 31472255
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2024
• 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: ARISTOTLE® 24 GUIDEWIRE (SCIENTIA VASCULAR); FLEXOR® SHUTTLE® GUIDING SHEATH (COOK MEDICAL); VACLOK® VACUUM PRESSURE SYRINGE (MERIT MEDICAL)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male