MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG HELICAL XTRSOFT COIL 2X4; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640HX0204
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that prior to the endovascular embolization procedure, the device packaging was opened and the device, a 2mm x 4cm orbit galaxy helical xtrasoft coil (640hx0204 / 31032531) was partially pushed out of the introducer sheath to inspect the device.The physician encountered resistance and observed that the embolic coil component was unraveled / stretched.The device was not used in the patient; a new device was used as replacement for the procedure.There was no negative patient impact.On (b)(6) 2023, additional information was received.Per the information, the replacement coil was another 2mm x 4cm orbit galaxy helical xtrasoft (640hx0204).No additional damage other than the unraveled / stretched condition reported was noted on the complaint coil.There was no clinically significant delay in the procedure as a result of the reported issue.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section e.1: the initial reporter phone:(b)(6).The initial reporter email address was 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 (31032531) 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.
Additional 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 (b)(6) 2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.10.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation 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 2mm x 4cm orbit galaxy helical xtrasoft coil was received contained in the decontamination pouch.Visual inspection was performed.The coil component was observed to be inside the introducer tube.No appearance of damage was noted on the device.The returned device underwent microscopic inspection.Under magnification, it was observed that the coil was stretched and the blue stretch resistance fiber was exposed; the coil remained attached to the headpiece.The issue documented in the complaint that the coil was stretched was confirmed based on the coil appearance.The stretched condition suggests that the device was forcibly advanced and retracted through the introducer in an attempt to overcome the resistance encountered.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.According to the risk documentation, a coil unable to be inserted into the microcatheter is a potential issue that can occur during microcoil insertion due to an overly tightened rhv, which can cause force to be inadvertently applied, resulting in coil stretching.There is no indication that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (31032531) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instruction for use contains the following precautions and warnings: if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then, slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw, and examine the delivery catheter system.During coil retraction, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil.If not, the coil has been stretched, which could lead to premature detachment or coil fracture.If the one-to-one relationship does not exist, remove the infusion catheter and the detachable coil as an assembly and replace.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.

• Brand Name: OG HELICAL XTRSOFT COIL 2X4
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• 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 ; 303552-6892
• MDR Report Key: 18207777
• Report Number: 3008114965-2023-00838
• Device Sequence Number: 6465082
• Product Code: KRD
• UDI-Device Identifier: 10886704030713
• UDI-Public: 10886704030713
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2024

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: 02/28/2025
• Device Catalogue Number: 640HX0204
• Device Lot Number: 31032531
• 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: 11/13/2023
• Supplement Date Received by Manufacturer: 12/13/2023; 01/04/2024
• Initial Report FDA Received Date: 11/26/2023
• Supplement Report FDA Received Date: 12/13/2023; 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2023
• 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
• Patient Sex: Unknown