MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREPAK HELIFORM; CEREPAK HELIFORM XTRASOFT XL DETACHABLE COIL SYSTEM

Catalog Number	XHE120206
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization of the middle meningeal artery (mma) with mild tortuosity noted in the lateral external carotid artery (leca) and the left mma, a 2mm x 6cm cerepak heliform xtrasoft xl (xhe120206 / 31393529) was used through a plato® 17 microcatheter (scientia vascular).The detachment handle (mdh1 / lot# unknown) was used for the first two detachment attempts.After the failed detachment attempts with the handle, the manual break method was used, which also failed.The coil was removed, and another coil of the same size was used with success.There was no report of any negative patient impact nor any delay in the procedure.The left mma was successfully embolized with two more cerepak coils.On 27-dec-2024, additional information was received.Per the information the lot number of the detachment handle is not known.When the coil was removed from the patient, it was still attached to the delivery system.¿the coil was inspected on the back table and there was no visible damage to the delivery system that could have contributed to the detachment failure.¿ the coil was not stretched.There was no evidence of blood flow interruption as a result of the reported issue.The replacement coil was another 2mm x 6mm heliform coil and it was used with the same original detachment handle.
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 email address was not available / reported.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (31393529) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no internal actions 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 limited information available and without the product available for analysis, the reported issue documented in the complaint could not be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure and / or 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 later.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.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 HELIFORM
• Common Device Name: CEREPAK HELIFORM XTRASOFT XL DETACHABLE COIL SYSTEM
• 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: 21027290
• Report Number: 3008114965-2024-01241
• Device Sequence Number: 21093813
• Product Code: KRD
• UDI-Device Identifier: 10886704083948
• UDI-Public: (01)10886704083948(11)240723(17)270630(10)31393529
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/27/2024

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: XHE120206
• Device Lot Number: 31393529
• 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: 12/12/2024
• Initial Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2024
• 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: MECHANICAL DETACHMENT HANDLE; PLATO® 17 MICROCATHETER (SCIENTIA VASCULAR)
• Patient Sex: Unknown