MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL IC 71, 132 CM, CE, ASP. IND.; CATHETER, PERCUTANEOUS

Catalog Number IC71132CA

Device Problem Difficult to Remove (1528)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 02/14/2024

Event Type  Injury  

Manufacturer Narrative

Product complaint #
=
> (b)(4) information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section e1 ¿ initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 31041010 number, and no non-conformances related to the malfunction were identified.Withdrawal difficulty of the embovac device from the vessel could require the use of significant force.This could result in device separation, dissection, perforation, or other vessel damage.Per the instructions for use (ifu), the device should not be withdrawn from the vessel against resistance until the cause of the resistance is determined by fluoroscopy.Movement of the device against resistance could dislodge a clot, perforate a vessel wall, or damage the device.Nevertheless, the device may have contributed to the event of a cerebral hemorrhage.Additionally, the severity of the event is unknown.Based on this information, this event does meet us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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 company is seeking this information through the event investigation.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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3011370111-2024-00015 and 3008114965-2024-00271.

Event Description

It was reported, via a personal interaction, that an emboguard 87, 95 cm ((b)(6)), an embotrap iii 5 mm x 37 mm ((b)(6)), and an embovac ic 71, 132 cm, ce, asp.Ind.((b)(6)) was used for a mechanical thrombectomy procedure to treat an occlusion of the internal carotid artery (ica).During the procedure, the user reported catheter body/shaft-inadequate support and inflation difficulty of the emboguard device, withdrawal difficulty of the embotrap device into the guide/intermediate catheter, and withdrawal difficulty of the embovac device from vessel.During the use of the embotrap device, a thromboembolism occurred.Following the withdrawal difficulty of the embotrap and embovac devices, a cerebral hemorrhage was found.The severity of the events is unknown.The event was reported as such, ¿the procedure was a mechanical thrombectomy of internal carotid artery occlusion.The emboguard, embotrap iii, embovac were prepared and used according to ifu.The emboguard was placed and inflated at the lesion.A three-way valve was used instead of the supplied luer valve of emboguard.The emboguard was not stable and found out that the balloon was deflated spontaneously.The balloon was able to be reinflated without any problem, so there seemed to be no damage on the balloon.After several times of passes (unknown how many times), recanalization of internal carotid artery was achieved, but a thrombus moved to m2-3.The physician attempted to retrieve the thrombus by combined technique using the embotrap iii and embovac.The blood vessel had strong bends.During retrieval of the devices, resistance was felt.Re-sheath was performed, and after that bleeding was found.The patient condition was unknown.A continuous flush was done.The lesions were internal carotid artery and m2-3.Other concomitant devices were unknown.¿ no further information was made available at the time of this review.

• Brand Name: IC 71, 132 CM, CE, ASP. IND.
• Type of Device: 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: 18826428
• MDR Text Key: 336863215
• Report Number: 3008114965-2024-00271
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K191237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IC71132CA
• Device Lot Number: 31041010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: EMBOGUARD 87, 95 CM; EMBOTRAP III 5 MM X 37 MM
• Patient Outcome(s): Life Threatening