MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X6; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX0406
Medical Device Problem Codes	Failure to Advance (2524); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Section h.3: 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 (30651725) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00617.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 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.
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the complaint coil, a 4mm x 6cm orbit galaxy complex xtrasoft (640cx0406 / 30651725) was impeded in the distal end of the concomitant microcatheter, a 150cm x 5cm, 2 markers prowler select lpes (606s155x / 30763317) and could not pass through.The physician encountered significant resistance.The physician remove the coil and microcatheter from the patient¿s anatomy and switched to new devices to complete the procedure.It was reported that both devices were observed to be kinked / bent.There was no report of any negative patient impact.On (b)(6) 2023, additional information was received.The information indicated that the target aneurysm was a lobulated aneurysm (aneurysm size was unobtainable) on the internal carotid artery (ica).A continuous flush had been maintained through the microcatheter.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.There was significant resistance when the coil was approaching the tip of the microcatheter.No other coil went through the microcatheter prior to the complaint coil.The issue reported occurred during the advancement of the coil into the aneurysm.The information indicated that the microcatheter was repositioned over the coil while the coil was deployed / partially deployed out of the microcatheter.When the coil was removed, it was still attached to the delivery system.There was no blood flow restriction / reduction due to the reported issue.The replacement coil was another 4mm x 6cm orbit galaxy complex xtrasoft (640cx0406) and the replacement microcatheter was another 150cm x 5cm, 2 markers prowler select lpes (606s155x).The information confirmed there was no negative patient impact as a result of the reported issue.The reported issue did not result in any clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 4mm x 6cm orbit galaxy complex xtrasoft coil was received contained in the decontamination pouch.Visual inspection was performed.The coil component was observed to be in severely stretched condition and tangled with itself and with the concomitant microcatheter.Multiple kinks were found on the hypotube.Microscopic inspection was performed.Under magnification, it was observed that a portion of the coil was completely straightened and snapped.The blue stretch resistance fiber was exposed.The proximal fragment of the coil remained attached to the headpiece.The distal fragment of the coil is missing.The issue documented that the coil was found kinked cannot be evaluated since the coil was returned completely straightened.It is unknown if the coil fragment that was not returned presented the kink damage.The issue documented in the complaint that the coil was impeded in the distal end of the concomitant microcatheter could not be evaluated through functional testing since the coil returned severely stretched and broken.However, the multiple kink damages noted on the delivery system (hypotube) suggest that the device was forcibly advanced through the microcatheter in an attempt to overcome the resistance encountered.According to the risk documentation, the delivery system not maintaining integrity upon delivery during embolic coil introduction is a potential failure mode that can result in the coil not being delivered to the treatment site due to mishandling of the device during introduction.Continuous flush being interrupted during embolic coil introduction is another potential failure mode that can result in the coil not being delivered to the treatment site due to inappropriate drops from pressure bag, without an adequate flush, issues such as resistance between the coil and the microcatheter can arise.The amount of dried saline residues observed on the microcatheter suggests that the continuous flush may have not been adequate.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides 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.The stretched condition of the embolic coil was not originally reported in the complaint.With the limited information available, the most likely time of occurrence is during embolic coil retrieval where the coil eventually broke off.According to the risk documentation, product damage of the retrieved device is a potential failure mode that can occur during embolic coil retrieval due to the following: introducer not being seated all the way into the microcatheter hub.Insufficient opening of rhv.Incorrect delivery system/introducer handling and anchoring techniques (rezipping, zipper movement, introducer locking etc.) used.A review of manufacturing documentation associated with this lot (30651725) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The instructions for use (ifu) contains the following precautions and warning: 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.During coil retraction, verify under fluoroscopy that a one-to-one relationship exists between the delivery tube and the coil.If not, the coil has been stretched, which could lead to premature detachment or coil fracture.If the one-to-one relationship does not exist, remove the infusion catheter and the detachable coil as an assembly and replace.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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00617 and 3008114965-2023-00618.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 02-oct-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00617 and 3008114965-2023-00618.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 CMPLX XTRASOFT COIL 4X6
• 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): 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 ; 303552-6892
• MDR Report Key: 17684890
• Report Number: 3008114965-2023-00618
• Device Sequence Number: 20403708
• Product Code: KRD
• UDI-Device Identifier: 10886704030621
• UDI-Public: 10886704030621
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2023

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: 08/31/2023
• Device Catalogue Number: 640CX0406
• Device Lot Number: 30651725
• 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: 08/17/2023
• Supplement Date Received by Manufacturer: 10/02/2023; 10/09/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 10/02/2023; 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PROWLER SELECT LPES
• Patient Sex: Unknown