MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CEREPAK FREEFORM; CEREPAK FREEFORM DETACHABLE COIL SYSTEM

Catalog Number	SCR120615
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during inspection of trunk stock, the box of a freeform 6mm x 15 cm coil (scr120615, 31136146) was mislabeled.The box was labeled being a ¿uniform¿ instead of freeform.No patient injury was reported as the device was not clinically used.
Additional Manufacturer Narrative
Product complaint (b)(4).Section d2b ¿ procode: krd/hcg.Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.
Additional Manufacturer Narrative
Product complaint #:(b)(4).As reported by the field, during inspection of trunk stock, the box of a freeform 6mm x 15 cm coil (scr120615, 31136146) was mislabeled.The box was labeled being a ¿uniform¿ instead of freeform.No patient injury was reported as the device was not clinically used.The device was returned to j&j medtech for further evaluation.A sterile cerepak coil was received contained in the original sealed package.Upon receiving the device, visual inspection was performed and it was noted that the package was identified as a uniform coil, while the outer label was identified as a freeform coil.The packaging was opened, and the inner pouch had a label that identified the coil as a freeform coil.The issue reported regarding the mismatched carton and label was confirmed based on the discrepancies found in the packaging.The reported defect was confirmed to be originated during manufacturing process, this event requires corrective actions, and it will be addressed through cerenovus quality system.A manufacturing record evaluation was performed for the finished device 31136146 number, and no internal actions were initiated during its manufacturing process.However, as a result of the issue reported, an internal action has been initiated to perform further assessment and a stop shipment was initiated to stop distribution of lot 31136146.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Updated sections on this med watch: g3, g6, h2, h3, h6 and h11.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Additional Manufacturer Narrative
Product complaint(b)(4).Updated sections on this med watch: b4, d9, g3, g6, h2, h3 and h11.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: CEREPAK FREEFORM
• Common Device Name: CEREPAK FREEFORM 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 ; 3035526892
• MDR Report Key: 20460108
• Report Number: 3008114965-2024-01004
• Device Sequence Number: 7880678
• Product Code: KRD
• UDI-Device Identifier: 10886704083177
• UDI-Public: (01)10886704083177(17)260731(10)31136146
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2024

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: SCR120615
• Device Lot Number: 31136146
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 11/26/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/20/2024; 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown