MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 5X10; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0510
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, saline was leaking from the hub of the 5mm x 10cm orbit galaxy complex fill coil (640cf0510 / 30697545) and as a result, the physician could not detach the coil due to insufficient pressure.It was reported that the physician ¿felt something wrong with the hub.¿ the coil was removed from the patient and another of the same product was used as replacement and the procedure was successfully completed.There was no report of any patient adverse event or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).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.A review of manufacturing documentation associated with this lot (30697545) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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.
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.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, saline was leaking from the hub of the 5mm x 10cm orbit galaxy complex fill coil (640cf0510 / 30697545) and as a result, the physician could not detach the coil due to insufficient pressure.It was reported that the physician ¿felt something wrong with the hub.¿ the coil was removed from the patient and another of the same product was used as replacement and the procedure was successfully completed.There was no report of any patient adverse event or complication.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 5mm x 10cm orbit galaxy complex fill coil was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the hypotube is severely kinked and the embolic coil is outside of the introducer.The hub was observed to be without any damage.The returned complaint device was inspected under a microscope.Under magnification, there was no damage observed on the embolic coil (i.E., no elongations, kinks, nor non-concentric loops).No damage nor abnormality was observed on the hub.The complaint device was connected to a lab sample syringe and flushed until the gauge reached the green zone.No leak was observed on the hub at this time.Based on this evidence, the reported issue documented in the complaint regarding a luer hub leakage could not be confirmed.It is possible that when the healthcare professional fitted the hub of the delivery tube to the luer valve, this was not properly engaged, which resulted in the leakage (insufficient pressure) observed during the procedure; however, this cannot be conclusively determined.No damages were found in the device that may have contributed to the issue experienced during the procedure.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.The multiple kinks found on the hypotube are not originally reported in the complaint and may have appeared during the post-operative handling of the device, where excessive force was inadvertently applied.However, these conditions are not related to the reported complaint.It should be noted that failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if saline fluid leaks from the syringe, or the threaded plunger strips and does not allow the syringe to obtain the required pressure anytime during the detachment procedure, the syringe should be replaced.A review of manufacturing documentation associated with this lot (30697545) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.H.6: the investigation findings ¿deformation problem (c070601)¿ is associated with the multiple kinks observed on the hypotube not originally reported in the complaint.This code is associated with the investigation conclusions ¿cause not established (d15).¿ the reported issue in the complaint was not confirmed through functional evaluation and analysis.This is documented in the investigation findings ¿no device problem found (c19)¿ and its associated investigation conclusions ¿no problem detected (d14).¿ updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.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 that the product was received in the product analysis lab on (b)(6) 2022.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: OG TDL CMPLX FILL COIL 5X10
• 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. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15219032
• Report Number: 3008114965-2022-00515
• Device Sequence Number: 17824982
• Product Code: KRD
• UDI-Device Identifier: 10886704030294
• UDI-Public: 10886704030294
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K093973
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/14/2022

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: 10/31/2023
• Device Model Number: 640CF0510
• Device Catalogue Number: 640CF0510
• Device Lot Number: 30697545
• 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: 07/26/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 09/14/2022
• Initial Report FDA Received Date: 08/12/2022
• Supplement Report FDA Received Date: 08/25/2022; 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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