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

Catalog Number	SCR120615
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).There was no patient involvement.Section d.2b: procode is krd/hcg.Section h.3: 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.The product analysis team reviewed the photos received on 16-oct-2024.Review is documented below.[photo review]: three (3) photos were received via email and added to the complaint file.The photos show clearly that the carton identifies a uniform coil, while the labeling describes a freeform coil.No other damage or relevant details can be observed.A manufacturing record evaluation was performed for the finished device 31136146 number, and no non-conformances were initiated during its manufacturing process.However, as a result of the issue reported, a non-conformance has been initiated to perform further assessment and a stop shipment was initiated to stop distribution of lot 31136146.This investigation was performed based only on the photos provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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.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.
Event or Problem Description
It was reported by the cerenovus representative that the during a proactive trunk stock inventory, a cerepak uniform coil box has a cerepak freeform label printed on the spine for a 6mm x 15cm cerepak freeform (scr120615 / 31136146).This is an incorrect label for the cerepak uniform.There was no facility or patient involvement.On 16-oct-2024, an email with three photos was received.The photos will be reviewed by the product analysis team.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 15-nov-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, g.3, g.6.H.2, h.3, h.6, and h.11.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).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a sterile cerepak coil was received contained in the original sealed package.Visual inspection was performed.It was noted that the package was identified as a uniform coil, while the outer label identified a freeform coil.The packaging was opened, and the inner pouch has a label that identify 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 non-conformances 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 the distribution of lot 31136146.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.

• 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: 20500807
• Report Number: 3008114965-2024-01005
• Device Sequence Number: 17984197
• Product Code: KRD
• UDI-Device Identifier: 10886704083177
• UDI-Public: (01)10886704083177(11)230817(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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2024

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 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: 10/03/2024
• Supplement Date Received by Manufacturer: 11/15/2024; 11/27/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/15/2024; 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