MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASH 14 PLAT COIL 4MMX6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	SRC140406-20
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode is krd/hcg.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.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during a coil embolization, a cash 14 plat coil 4mmx6cm coil (src14040620, l15473) would not detach due to no green light on the detachment box.The coil was not checked prior to the use of the coil.The coil was removed from the aneurysm and the same microcatheter, control cable and box were used in this case.This was not the first coil used in the case and the other coils used detached without any issues.No significant delay in treatment.No negative impact on patient condition.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated section on this medwatch report: b4, g3, g6, h2, h3 h6 and h10.Complaint conclusion: as reported by the field, during a coil embolization, a cash 14 plat coil 4mmx6cm coil (src14040620, l15473) would not detach due to no green light on the detachment box.The coil was not checked prior to the use of the coil.The coil was removed from the aneurysm and the same microcatheter, control cable and box were used in this case.This was not the first coil used in the case and the other coils used detached without any issues.No significant delay in treatment.No negative impact on patient condition.No additional information is available.A non-sterile cash 14 plat coil 4mmx6cm was received contained in the decontamination pouch.Upon receiving the device, a visual inspection was performed, and the coil component was found inside the introducer.No apparent damages were observed.The device was inspected under magnification, and it was found that the coil was in good normal condition.The distal outer sheath had not been softened, indicating that the resistance heating (rh) coil had not been heated and the detachment process was not initiated.The electrical resistance of the cash 14 plat coil 4mmx6cm device was measured with a multimeter, and it measured 52.6 ohms o, which is within the specification range.Also, the device was connected to a lab sample detachment control box (dcb) dcb00000500, and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed, and a beep sound was heard; the coil became detached from the unit without difficulty.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated in the lab setting.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issue from occurring.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required at this time.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following caution: verify that the microcoil delivery system is fully connected and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil as described in the following section, re-sheathing the microcoil system, and replace with a new microcoil system.If the system is free of faults, depress the detach button on the enpower dcb or the enpower control cable.The detach cycle light next to the button will illuminate and an intermittent tone will sound for the duration of the detachment cycle.If the light and audible tone do not activate, replace the dcb.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 04-apr-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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: CASH 14 PLAT COIL 4MMX6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16599257
• Report Number: 3008114965-2023-00191
• Device Sequence Number: 11187429
• Product Code: KRD
• UDI-Device Identifier: 00878528004141
• UDI-Public: 00878528004141
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K022420
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/01/2023

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: 03/31/2024
• Device Model Number: SRC140406-20
• Device Catalogue Number: SRC14040620
• Device Lot Number: L15473
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 04/10/2023
• Initial Report FDA Received Date: 03/23/2023
• Supplement Report FDA Received Date: 04/04/2023; 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2019
• 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