MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX FILL COIL 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number 640CF0306

Device Problems Stretched (1601); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, the complaint device, a 3mm x 6cm orbit galaxy mini complex fill (640cf0306 / 30937878) was impeded at the distal end of the concomitant sl-10® microcatheter (stryker) and could not pass through the microcatheter.The physician retracted the coil and observed that it had unraveled / stretched.A new coil was used as replacement to complete the procedure using the original microcatheter.There was no report of any negative patient impact.

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 (30937878) 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 25-dec-2023.[additional information]: on 25-dec-2023, additional information was received.The information indicated that there was resistance between the guidewire and microcatheter when the target site was being accessed.Prior to the complaint coil, other coils did go through the same microcatheter without resistance.The reported issue occurred during insertion through the microcatheter, before exiting the microcatheter.There was a one-to-one relationship between the coil and delivery wire verified with fluoro prior to repositioning.There were no additional damages noted on the coil aside from the reported stretched / unraveled condition when it was removed.There was no blood flow restriction / reduction as a result of the reported issue.There was no clinically significant delay in the procedure from the reported issue.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.

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 3mm x 6cm orbit galaxy mini complex fill was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The coil component was inspected under microscopic magnification, it was found that the embolic coil is in good normal conditions (i.E., no elongations, kinks, or non-concentric loops were noted).A lab sample prowler select plus microcatheter was flushed until the water was coming out from the distal end.Then, the orbit galaxy was introduced into the microcatheter, and it advanced; the orbit galaxy could be advanced until it came out from the distal tip of the microcatheter without 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 reported during the procedure.The reported issue in the complaint cannot be confirmed with the evidence available.It is possible that other clinical and procedural factors that cannot be replicated during the analysis may have contributed to the reported failure.A review of manufacturing documentation associated with this lot (30937878) 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.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.

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 09-jan-2024.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 CMPLX FILL COIL 3X6
• Type of Device: 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 ; 303552-689
• MDR Report Key: 18307764
• MDR Text Key: 330463940
• Report Number: 3008114965-2023-00892
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030218
• UDI-Public: 10886704030218
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 640CF0306
• Device Lot Number: 30937878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2023
• Initial Date FDA Received: 12/11/2023
• Supplement Dates Manufacturer Received: 12/25/2023; 01/09/2024; 01/15/2024
• Supplement Dates FDA Received: 12/26/2023; 01/09/2024; 01/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SL-10® MICROCATHETER (STRYKER)