MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL IC 71, 125 CM, CE, ASP. IND.; CATHETER, PERCUTANEOUS

Catalog Number	IC71125CA
Medical Device Problem Codes	Material Puncture/Hole (1504); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a thrombectomy, the user used the embovac aspiration catheter to aspirate the thrombus through segment m1, then pulled it back, causing the stretch to collapse and ¿break the hole¿.There was no patient injury reported.Additional event information received on 26-aug-2024 indicated that there was a slight procedural delay due to the vent.The term of ¿break the hole¿ was further clarified as having a ¿hole¿.The device did not separate into 2 or more fragments.Adapt ((direct aspiration first pass technique) was performed in this case.The devise was not snaked.There was regular tortuosity in the internal carotid artery, cavernous segment (c4).
Additional Manufacturer Narrative
Product complaint (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.
Additional Manufacturer Narrative
Product complaint (b)(4).Updated sections on this med watch.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint (b)(4) updated sections on this med watch: b4, g3, g6, h2, h3, h6 and h11.Complaint conclusion: as reported by the field, during a thrombectomy, the user used the embovac aspiration catheter to aspirate the thrombus through segment m1, then pulled it back, causing the stretch to collapse and ¿break the hole¿.There was no patient injury reported.Additional event information received on 26-aug-2024 indicated that there was a slight procedural delay due to the vent.The term of ¿break the hole¿ was further clarified as having a ¿hole¿.The device did not separate into 2 or more fragments.Adapt ((direct aspiration first pass technique) was performed in this case.The devise was not snaked.There was regular tortuosity in the internal carotid artery, cavernous segment (c4).A non-sterile ic 71, 125 cm, ce, asp.Ind.Was received contained in the decontamination pouch.Upon receiving the device, visual inspection was performed, and one (1) stretched section of 3.50 cm was noted on the distal end of the catheter.Further inspection on the microscope revealed that as a result of the severity of the stretching the internal braided mesh was exposed.The issues reported regarding a catheter being stretched and then collapsed into a hole were confirmed based on the damages found on the received device; however, factors not described in the information provided, such as patient¿s anatomy, device manipulation, and operator¿s technique, may have contributed to the issue encountered.According to the risk documentation a damaged catheter is a potential issue that can occur during withdrawal of catheter.With the limited information available, a conclusive cause cannot be determined, however, given the broad sequence of events, there is no indication that the issue reported in the complaint is related to a manufacturing issue.A manufacturing record evaluation was performed for the finished device 31027261 number, and no non-conformance's related to the malfunction were identified.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages such as catheter stretching and kinking from leaving the facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure could be caused by multiple factors.The instructions for use contain the following precaution: exercise care in handling the intermediate catheter to reduce the chance of accidental damage.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: IC 71, 125 CM, CE, ASP. IND.
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• 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 ; 3035526892
• MDR Report Key: 20169961
• Report Number: 3008114965-2024-00878
• Device Sequence Number: 15516535
• Product Code: NRY
• UDI-Device Identifier: 10886704082361
• UDI-Public: (01)10886704082361(17)240831(10)31027261
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K191237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Catalogue Number: IC71125CA
• Device Lot Number: 31027261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 09/09/2024; 09/23/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/17/2024; 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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
• Patient Sex: Unknown