MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL LARGE BORE CATHETER; CATHETER, ASPIRATION CATHETER

Catalog Number	IC71132UG
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	10/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref#: (b)(4).Section a1.Patient identifier: (b)(6).Section d2b: procode is nry/qjp.The device was not received for analysis; therefore, no product investigation can be performed and the reported failure could not be evaluated.A manufacturing record evaluation was performed for the finished device 31054024 number, and no non-conformances related to the malfunction were identified.Catheter kinking/damage during clinical use is a known and common occurrence occurring during angiography and is typically related to anatomy, technique, skill, and vessel tortuosity.The instructions for use cautions users to inspect for kinks and bends, or other signs of damage prior to and during use.Any product with damage is not to be used.If the operator encounters kinking or damage during use, they are clinically trained to immediately discontinue manipulations and remove the product.Therefore, the potential for patient injury/death occurring as a result of kinking or bend type damage is remote.Additionally, interference or friction between devices is a known occurrence.Removal and exchange of devices is common routine practice in endovascular procedures.If resistance is encountered, the system being inserted should be withdrawn as a unit to prevent injury.In this case, it is done without loss of cerebral target position.This is a common practice during procedures and is recommended in product ifu¿s.Since the vast majority of diagnostic and interventional angiographic procedures utilize multiple device exchanges, an increased potential for patient injury is remote.In this case, it was reported the device deficiency did not result in patient harm, therefore, this does not meet us fda reporting criteria.Arterial occlusion is a known potential complication associated with the use of the embovac study device and is mentioned in the instructions for use (ifu) as such.The principal investigator assessed the event of ¿reocclusion of l m1¿ as not related to the study device and procedure; however, the clinical event committee (cec) adjudication deemed the events as ¿possibly related¿ to the large bore catheter.Based on this assessment, the correlating relationship between the events to the used embovac study device cannot be ruled out entirely.Additionally, the event was assessed as serious adverse event, and the event required prolonged hospitalization and medicinal treatment.Based on the assessment of the clinical event committee (cec), this event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury,¿ with an awareness date of 24-jun-2025.The file will be re-reviewed if additional information is received at a later date.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.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.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.
Event or Problem Description
As reported via the excellent study (cnv_2017_02), a 61-year-old male (subject (b)(6)) with a medical history of hyperlipidaemia and hypertension, and active smoker, presented with an unwitnessed stroke on an unknown date and time.The patient was then presented to the treating hospital on (b)(6) 2023, time unknown, where ct imaging confirmed an ischemic stroke.Intravenous tissue plasminogen activator (tpa) was not administered at the time of stroke presentation.The suspected origin of the embolism was ¿small-vessel disease.¿ the patient¿s baseline nihss score was 11 and modified rankin scale (mrs) score of ¿0- no symptoms.¿ on (b)(6) 2023, the patient underwent an endovascular mechanical thrombectomy using an 132cm embovac large bore 71 catheter (ic71132ug/ 31054024) for occlusions at the m1 and m2 segments of the right middle cerebral artery (mca).The pre-pass mtici score was 0.The first two passes were made using a direct contact aspiration device alone at the m1 right occlusion site, which resulted in a mtici score of 2b, with clot retrieval for the 1st pass only.The third pass was made at the m2 right occlusion site, which resulted in a mtici score of 2b, with no clot retrieval.During the procedure, a guidewire was used, but the brand was not specified.A 0.035 zoom 35 microcatheter was also used.There was a device deficiency during the procedure.The embovac catheter ¿was inadvertently bent due to resistance following the first pass causing it to kink.A new lbc was then pulled and utilized.¿ the event occurred during ¿post deployment of the device/after attempted aspiration with the device.¿ the event was classified as a use error.No adverse event resulted from the device deficiency.The patient¿s 24-hour post-procedure nihss assessment score was 8.On (b)(6) 2023, the patient experienced the event of ¿right m1 occlusion,¿ which was made known to the site on the same day and to the sponsor on (b)(6) 2023.The principal investigator (pi) assessed this event as serious, severe in severity, and as not related to the embotrap iii study device, not related to the embovac large bore catheter, and not related to the primary surgical procedure.The event was treated with medication.The event required hospitalization; the patient was admitted on (b)(6) 2023, and the patient¿s discharge date was on (b)(6) 2023.The outcome is recorded as ¿unknown,¿ with no end date listed.One (b)(6) 2024, the patient was discharged home for self-care, with an nihss score of 4 and an mrs score of ¿3-moderate disability.Requires some help, but able to walk without assistance.¿ additional/modified information was received on 24-jun-2025.Summary: on 19-jun-2025, a clinical event committee (cec) adjudication for the adverse event of ¿mca reocclusion¿ was received.The relationship of event to the embotrap study device was assessed as ¿not related,¿ the relationship of event to the study procedure, and to large bore catheter were assessed as ¿possibly related.¿ the event required in-patient hospitalization or prolonged hospitalization.The cec adjudicated event term was updated from ¿right m1 occlusion¿ to ¿mca reocclusion.¿ it was further commented, ¿event occurred day 7.¿.

• Brand Name: LARGE BORE CATHETER
• Common Device Name: CATHETER, ASPIRATION CATHETER
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22360095
• Report Number: 3008114965-2025-00661
• Device Sequence Number: 18319369
• Product Code: DQY
• UDI-Device Identifier: 10886704082378
• UDI-Public: (01)10886704082378(17)240930(10)31054024
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: IC71132UG
• Device Lot Number: 31054024
• 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: 06/24/2025
• Initial Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TRACSTAR LONG SHEATH; ZOOM 35 MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White