MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREPAK FREEFORM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	XCR120620
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an arteriovenous malformation procedure, the 6mm x 20cm cerepak freeform xtrasoft (xcr120620 / 31218777) did not detach.It was reported that ¿system was all straight and in line during detachment.¿ two attempts were made to detach via the cerepaktm detachment handle (mdh1 / 102109430).Then manual detachment was made without the handle.During the final attempt, the wire was put to 90-degree between mechanical detachment indicators which was also unsuccessful.When finally pulling the coil back into the microcatheter (unspecified brand), the physician ¿did feel a snap and then the coil detach, but [it] was not in the target location.¿ the physician was able to remove the whole system to ensure the coil was not left behind.There was no report of any negative patient impact.On 22-oct-2024, additional information was received.The location of the targeted avm is not known.The lot number of the detachment handle is 102109430.The information indicated that manual attempt was made once.The coil became detached as it was being pulled back into the microcatheter.The coil was not stretched nor did it become separated into two or more pieces.The concomitant microcatheter used was a headway® duo microcatheter (microvention).There was no evidence of blood flow interruption as a result of the reported issue.The coil was replaced by a target xl coil (stryker).The information indicated that the procedure was successfully completed.The physician implanted a total of 12 target xl coils followed by trufill® n-bca liquid embolic system.There was no negative impact on the patient.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (31218777) 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 johnson & johnson medtech, or its employees that the report constitutes an admission that the product, johnson & johnson medtech, 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.

• Brand Name: CEREPAK FREEFORM
• 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: 20517024
• Report Number: 3008114965-2024-00977
• Device Sequence Number: 20762969
• Product Code: KRD
• UDI-Device Identifier: 10886704083726
• UDI-Public: (01)10886704083726(11)240102(17)261231(10)31218777
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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 Catalogue Number: XCR120620
• Device Lot Number: 31218777
• 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: 10/10/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2024
• 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 MICROCATHETER (MICROVENTION); MECHANICAL DETACHMENT HANDLE
• Patient Sex: Male