MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 2.5X5; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX2505
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the photo review of the complaint device that was included in the complaint.This mdr submission also includes the additional information received on 24-jul-2024.[photo review]: one photo was included in the complaint that shows the embolic coil out of the introducer.The embolic coil is in severely stretched condition exposing the blue fiber.The coil was noted to still be attached to the gripper.No other damages can be seen as the complete device is not shown in the photo.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.The issue reported regarding the coil being impeded in the introducer sheath cannot be evaluated through a picture; however, the reported issue documented in the complaint is confirmed based on the severe stretched condition of the coil that could have been the result of the difficulties experienced to overcome the impeded condition felt.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.[additional information]: on 24-jul-2024, additional information was received with feedback from the cerenovus sales representative.Per the information, the coil was impeded in the introducer sheath and could not be pushed into the microcatheter.The physician retracted the coil and found that the coil had unraveled / stretched.The coil was not used in the patient; the physician replaced it with a new coil to complete the procedure using the same microcatheter.There was no report of any patient injury.The information indicated that the coil was unraveled / stretched before it was used in the patient, therefore, the sales representative did not report it.It was communicated with the sales representative that when the device is used according to the instructions for use (ifu), all problems (complaints) encountered during the procedure should be reported.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).Information regarding patient identifier, date of birth, age, sex, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone is not available / reported.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 2.5mm x 5cm orbit galaxy complex xtrasoft was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil was observed still attached to the delivery system; it was outside of the introducer sheath and in severely stretched condition.No other damages were observed on the rest of the device.A review of manufacturing documentation associated with this lot (31025935) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.The issue reported regarding the coil becoming impeded in the introducer sheath could not be evaluated due to the severe stretched condition of the coil.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.The stretched condition of the embolic coil was not originally reported in the complaint.With the limited information available, the most likely time of occurrence is during embolic coil retrieval.According to the risk documentation, product damage of the retrieved device is a potential failure mode that can occur during embolic coil retrieval due to the following: introducer not seated all the way into the microcatheter hub.Insufficient opening of rotating hemostasis valve (rhv).Incorrect delivery system/introducer handling and anchoring techniques (rezipping, zipper movement, introducer locking etc.) used.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains the following precaution and warning: 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.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.
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the complaint coil, a 2.5mm x 5cm orbit galaxy complex xtrasoft (640cx2505 / 31025935) was impeded in the introducer sheath and could not be pushed into the microcatheter.The physician retracted the coil and replaced it with a new coil to complete the procedure using the same original microcatheter.There was no negative impact to the patient.On 05-jun-2024, it was reported by the sales representative that no additional information can be obtained.The complaint device was returned and received on 21-jun-2024.Based on the result of the product analysis completed on 10-jul-2024, the reported issue meets usfda reporting criteria under 21 cfr 803 as a "malfunction.".

• Brand Name: OG CMPLX XTRASOFT COIL 2.5X5
• 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: 19714621
• Report Number: 3008114965-2024-00682
• Device Sequence Number: 15648006
• Product Code: KRD
• UDI-Device Identifier: 10886704030652
• UDI-Public: (01)10886704030652(11)230307(17)250228(10)31025935
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: 640CX2505
• Device Lot Number: 31025935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND)
• Patient Sex: Unknown