MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM XSFT 4MM X 10 CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	XCR120410
Medical Device Problem Codes	Material Separation (1562); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, sex, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (31136148) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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.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 or Problem Description
The healthcare professional reported that during a coil embolization procedure targeting a ruptured aneurysm located on the left middle cerebral artery (mca), coils were placed through the headway® duo 156 microcatheter (microvention).Each product used during the procedure was in accordance with the instructions for use (ifu).The first coil was a 5mm x 17cm cerepak uniform coil but it was too small.The second coil was a 7mm x 30cm cerepak uniform but the coil was too large; there were no reported issues with these first two coils.The third coil was a 6mm x 26cm cerepak uniform (fcx100626 / 31177724).The detachment handle (mdh1 / 102109430) was used, but the coil failed to detach after the first attempt.Manual break was successfully attempted.The fourth coil was a 4mm x 10cm cerepak freeform xsft (xcr120410 / 31136148).This coil failed to detach after the first attempt using the handle.Manual break attempt was also unsuccessful and the pull wire sheared off.The fourth, failed to detach coil was removed from the patient.The fifth coil was a 3mm x 6cm cerepak freeform mini (mcr093060 / 31162595).Attempt to detach the fifth coil via the handle was not successful.Manual break was successfully performed and the coil effectively detached, although with a broken pull wire.The sixth coil was another 3mm x 6cm cerepak freeform mini (mcr093060) from the same lot (31162595) was used with a new detachment handle (mdh1) also from lot 102109430.The detachment handle failed to detach this sixth coil.Manual break was successfully attempted but with a broken pull wire.The procedure was reportedly successfully completed with a 10-minute procedure delay.It was reported that when the reported issues were encountered, the physician was requested to follow the ifu protocol.There was no report of any negative patient impact.On 21-aug-2024, additional information was received.Per the information, the procedure date was (b)(6) 2024.The information indicated that the first and second coils (5x17 uniform and 7x30 uniform) were not used; it confirmed that the third coil, 6mm x 26cm cerepak uniform was successfully detached via manual break and implanted.The information confirmed that the fourth coil, a 4mm x 10cm cerepak freeform xsft (xcr120410 / 31136148), failed to detach.When it was removed after it failed to detach, it was still attached to the delivery system; it was not known if the coil was stretched when it was removed.The fifth and sixth coils: from the same lot number were detached via manual break and were implanted.The procedure was completed after the detachment and implantation of the sixth coil.The information also indicated that the 10 minutes procedure delay was not considered to be clinically significant, but ¿it caused significant frustration.¿.

• Brand Name: FREEFORM XSFT 4MM X 10 CM
• Common Device Name: 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 ; 303552-6892
• MDR Report Key: 20070179
• Report Number: 3008114965-2024-00836
• Device Sequence Number: 15660098
• Product Code: KRD
• UDI-Device Identifier: 10886704083689
• UDI-Public: (01)10886704083689(11)230815(17)260731(10)31136148
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2024

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: 07/31/2026
• Device Catalogue Number: XCR120410
• Device Lot Number: 31136148
• 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: 08/19/2024
• Initial Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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: HEADWAY® DUO 156 MICROCATHETER (MICROVENTION).; MECHANICAL DETACHMENT HANDLE.
• Patient Age: 76 YR
• Patient Sex: Unknown