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

Model Number	SRC140406-20
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
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.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.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, a cash 14 plat coil 4mmx6cm (src14040620, l15473) was advanced through a headway duo 156cm microcatheter.The coil became stretched to the point that the coil was not present when the delivery system of the coil was removed from the body.The coil was not left inside body.It is presumed that it is still in the microcatheter.The headway was taken out and replaced with a different headway duo.The case was completed without issue with new microcatheter.
Additional Manufacturer Narrative
Product complaint #(b)(4).Complaint conclusion: as reported by the field, a cash 14 plat coil 4mmx6cm (src14040620, l15473) was advanced through a headway duo 156cm microcatheter.The coil became stretched to the point that the coil was not present when the delivery system of the coil was removed from the body.The coil was not left inside the patient's body.It is presumed that it is still in the microcatheter.The headway was taken out and replaced with a different headway duo.The case was completed without issue with new microcatheter.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 it was noted that the coil is severely stretched and tangled with the rest of the unit.The coil component was inspected under microscopic magnification, it was found that the blue fiber was broken; however, the coil is in one piece.The coil remains attached to the resistance heating (rh) and this was found not softened indicating that the detachment process was not initiated.The issue documented regarding coil stretching was confirmed based on the appearance of the returned coil, however, the issue regarding a premature detachment was not confirmed since the coil was found still attached to the rh.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provide proper handling instructions for the device to prevent such issues from occurring.Stretching can occur during procedure handling where force may have been inadvertently applied.According to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement due to continuous saline flush not being established, which can result in coil stretching.It is possible that the microcatheter lumen was not sufficiently lubricated, causing friction.There is no indication that the issue reported is a result of a defect inherently related to the device.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damages such as coil damage from leaving the 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 multiple factors could cause product failure.The instructions for use (ifu) does contain the following recommendation: if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.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: 16408078
• Report Number: 3008114965-2023-00121
• Device Sequence Number: 5898615
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/05/2023

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: 01/30/2023
• Supplement Date Received by Manufacturer: 04/04/2023; 05/04/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 04/04/2023; 05/05/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY DUO 156CM MICROCATHETER
• Patient Sex: Unknown