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| Catalog Number |
UNKCEREBASE |
| Medical Device Problem Code |
Crack (1135)
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| Health Effect - Clinical Code |
No Clinical Signs, Symptoms or Conditions (4582)
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| Date of Event |
12/29/2024
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Type of Reportable Event
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Malfunction
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Additional Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 05-mar-2025.[additional information]: on 05-mar-2025, additional information was received.The information indicated that the procedure was a mechanical thrombectomy with the target vessel being the m1 segment of the middle cerebral artery (mca).It was not an adapt (direct aspiration first pass technique) case.The reported issue with the cerebase occurred intra-op, because the ¿cerebase not damaged as taken out of packaging, inserted as usual.During first run, noticed leakage at the hub site.¿ the cerebase was replaced with ¿another cerebase.Unsure of lot number.¿ the information confirmed there was no negative impact to the patient and no clinically significant delay in the procedure.Updated sections: b.4, g.3, g.6, h.2, and h.11.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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Additional Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that multiple attempts to obtain product for analysis were unsuccessful.If product is returned or information provided at a later date, the file will be updated accordingly.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 product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.The lot number of the device is not known; therefore, manufacturing documentation review 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 failure.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.
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Additional Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 17-mar-2025.[additional information]: on 17-mar-2025, additional information was received that provided the device lot number (31403082).A review of manufacturing documentation associated with this lot (31403082) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.Updated sections: b.4, d.4, g.3, g.6, h.2, h.4, h.6, and h.11.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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Additional Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 95cm cerebase straight da guide sheath was received contained in the decontamination pouch.Visual inspection was performed.The luer hub was observed cracked at the fusion point area.The cerebase was flushed with water using a lab sample syringe.Water leakage was observed on the damaged area.The reported issue that the hub was cracked was confirmed during the inspection.According to risk documentation hub damage during attachment of hemostasis valve is a potential failure mode that can result from the handling of hemostasis valve and hub, where excessive force could have been applied, leading to damage to the device.Other circumstances or problems may have occurred during the use of the device that could not be replicated during the analysis.A review of manufacturing documentation associated with this lot (31403082) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions related to device manufacture or inspection.As part of johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached as to the cause of the event reported, the instruction for use (ifu) contains the following precautions: - exercise care in handling the cerebase da guide sheath to reduce the chance of accidental damage.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.
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Additional Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.4: the product catalog and lot numbers are not available / not reported.The unique identifier (udi) and expiration date of the device are not available.Section e.1: the initial reporter phone: (b)(6).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.Section h.4: the device manufacture date is not known as the device lot number is not available / not reported.The full udi is not available without the manufacture date.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.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.
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Event or Problem Description
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The healthcare professional reported that during a procedure on (b)(6) 2024, the hub of the cerebase device (catalog / lot# unknown) was cracked.When saline was being injected, it was not flowing through the catheter; it was coming out at the cracked hub.There was no negative patient impact reported.
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Additional Manufacturer Narrative
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Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 23-apr-2025.A supplemental 3500a report will be submitted once the product investigation has been completed.The report will also include a correction to the primary udi number.Corrected section: d.4: primary udi number.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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Search Alerts/Recalls
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