MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X7.5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3575
Medical Device Problem Codes	Stretched (1601); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone and email address are not available / 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.A review of manufacturing documentation associated with this lot (30768931) 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 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, there was resistance while pushing the complaint coil, a 3.5mm x 7.5cm orbit galaxy complex xtrasoft (640cx3575 / 30768931) in the concomitant microcatheter (unspecified brand).While removing the coil from the microcatheter, it became stretched.The procedure was successfully completed but was delayed by 10 minutes.There was no report of any negative patient impact.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 3.5mm x 7.5cm orbit galaxy complex xtrasoft was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed on the device.The embolic coil component was inspected under the microscope.Under magnification, it was observed that the embolic coil is in good, normal condition (i.E., no elongations, no kinks or concentric loops were noted), the embolic coil still remains connected to the gripper.Residues of dried blood were found inside the gripper.A lab sample prowler select plus microcatheter was flushed until water was coming out from the distal end.The complaint device was then introduced into the microcatheter and it advanced; the returned 3.5mm x 7.5cm orbit galaxy complex xtrasoft coil could be advanced until it exited the distal tip of the microcatheter without any noticeable resistance.The functional test was performed successfully with one sample prowler select plus, the device was able to pass through the entire length of the microcatheter without significant resistance.Additionally, no other damages were found on the orbit galaxy that could have contributed to the issue.The event as reported cannot be confirmed with the evidence available since the coil was found undamaged and performed successfully during the functional test.It is possible that a continuous flush had not been done, without an adequate flush, issues such as resistance between the coil and the microcatheter can arise.However, other factors not described in the event description may have contributed to the issue encountered during the procedure and could not be replicated in the laboratory setting.With the evidence available, there is no indication that the issue reported in the complaint results from a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30768931) 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 could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.If unusual friction is noted within the infusion catheter, remove the detachable coil system.If friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.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.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) 2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, 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 include the additional event information received on 10-apr-2023.[additional information]: on 10-apr-2023, additional information was received.The information indicated that the coil embolization procedure was targeting a 4mm anterior communicating artery (acom) aneurysm.Neck remodeling was not used.The microcatheter used was a 150cmx5cm, 2markers, 45tip prowler select lpes (606s155fx /30763314).A continuous flush was maintained through the microcatheter.The same microcatheter was used to complete the procedure.There was no resistance between the guidewire and the microcatheter when the target site was being accessed.There were no kinks in the microcatheter that could have contributed to the reported issue.Prior to this coil, three (3) other coils went through the microcatheter without any issue.The resistance encountered with the complaint coil was in the hub of the microcatheter.It was encountered during insertion through the microcatheter before exiting it.The same microcatheter was used to complete the procedure.The microcatheter was not repositioned over the coil while the coil.Coil entanglement with previously placed coil was not suspected to contribute to the reported event.No additional intervention was needed, the entire coil was removed and the outcome was reported to be good.The coil was stretched and then prematurely detached.There was no blood flow restriction / reduction as a result of the reported issue.The replacement coil used to complete the procedure was a 3mm x 8cm orbit galaxy complex xtrasoft coil (640cx0308).The physician did not consider the reported 10-minute delay in the procedure to be clinically significant.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 3.5X7.5
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 16704673
• Report Number: 3008114965-2023-00193
• Device Sequence Number: 14348765
• Product Code: KRD
• UDI-Device Identifier: 10886704030706
• UDI-Public: 10886704030706
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 04/21/2023

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: 02/29/2024
• Device Model Number: 640CX3575
• Device Catalogue Number: 640CX3575
• Device Lot Number: 30768931
• 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: 03/21/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 04/14/2023; 04/21/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 04/10/2023; 04/14/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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 45 DEG TIP
• Patient Age: 36 YR
• Patient Sex: Male