MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM MINI 1.5MM X 3CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number MCR091530

Device Problems Fracture (1260); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, weight, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter email address is 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 as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (31045746) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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 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.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 Description

The healthcare professional reported that during an endovascular embolization procedure, the physician was coiling a posterior communicating artery (pcom) aneurysm using cerepak coils.He deployed four (4) coils without incident.The fifth coil, a 1.5mm x 3cm cerepak freeform mini (mcr091530 / 31045746) was inserted into the aneurysm without difficulty.Manual break technique was attempted but was unsuccessful due to the fracturing of the pull wire.The coil was removed without issue and was observed intact in the field.The physician added three (3) more cerepak coils to the aneurysm without detachment failure.There was no negative patient outcome.On 14-dec-2023, additional information was received.Per the information, the patient is a (b)(6) female with a 5mm x 4mm unruptured pcom aneurysm.The information indicated that the manual break technique was used on all cerepak coils.The concomitant microcatheter was a 0.0165-inch inner diameter sl-10® microcatheter (stryker).There was approximately five (5) minutes added to the procedure time in trying to get the coil to detach and trying to remove it carefully without causing other coils to prolapse out of the aneurysm.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 02-jan-2024.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

• Brand Name: FREEFORM MINI 1.5MM X 3CM
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; calle circuito int norte 1820; parque industrial salvacar; juarez 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18414113
• MDR Text Key: 331595490
• Report Number: 3008114965-2023-00958
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704082972
• UDI-Public: 10886704082972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCR091530
• Device Lot Number: 31045746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• 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: SL-10® MICROCATHETER (STRYKER)
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Race: White