MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL ENVOY DA, 6F, 105CM, MPD; PERCUTANEOUS CATHETER

Catalog Number	67125805D
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Section e1.(b)(6).Section h3 - the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.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.The company is seeking this information through the event investigation.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.
Event or Problem Description
As reported by the field, prior to the procedure, the physician opened the outer packaging of an envoy da, 6f, 105cm, mpd (67125805d, 31045688) and found that the sterile package was absent.The device was not used in patient.A new device was switched to complete the surgery.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, b5, d9, g3, g6, h2, h3 and h10.Section b5: additional event information received on 23-jan-2024 indicated that the device was stored and prepped as per the instructions for use (ifu).The shipping box and outer box were intact when the device was received.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).Complaint conclusion: as reported by the field, prior to the procedure, the physician opened the outer packaging of an envoy da, 6f, 105cm, mpd (67125805d, 31045688) and found that the sterile package was absent.The device was not used in patient.A new device was switched to complete the surgery.Additional event information received on 23-jan-2024 indicated that the device was stored and prepped as per the instructions for use (ifu).The shipping box and outer box were intact when the device was received.A non-sterile envoy da, 6f, 105cm, mpd was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and no apparent damage was observed.The device was returned without original package.The issue reported regarding the sterile package being absent cannot be confirmed.The issue was reported to have occurred before use; however, the device has been removed from its packaging and handled in an unknown manner and environment.With the information available and the lack of the original outer package and cardboard returned, a conclusive cause cannot be fixed on; factors not described within the information available such as device manipulation may have contributed to the issue encountered.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The device history records (dhr) for lot number 31045688 were reviewed and no evidence of deficiencies during the manufacturing process was found.No pieces were scrapped, and no non-conformances were generated during the manufacturing process.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection for pouch seal/damage before leaving the manufacturing facility.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required.It should be noted that product failure is multifactorial.The instructions for use (ifu) provides the following precautions: ¿ inspect the sterile package carefully.Do not use if: the package or seal appears damaged, contents appear damaged, or the expiry date has passed.¿ do not use a catheter that has been damaged in any way.If damage is detected, replace with another envoy da guiding catheter that is not damaged.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: ENVOY DA, 6F, 105CM, MPD
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18542646
• Report Number: 3008114965-2024-00093
• Device Sequence Number: 8915378
• Product Code: DQY
• UDI-Device Identifier: 10878528000676
• UDI-Public: 10878528000676
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/04/2024

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: 02/28/2026
• Device Catalogue Number: 67125805D
• Device Lot Number: 31045688
• 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: 12/30/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 02/18/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 01/23/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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
• Patient Sex: Unknown