MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 5X15; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number 640CF0515

Device Problems Material Separation (1562); Failure to Advance (2524); Premature Separation (4045)

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

Event Date 03/19/2024

Event Type  malfunction  

Event Description

The healthcare professional reported that during an endovascular embolization procedure, when the physician was delivery the 5mm x 15cm orbit galaxy complex fill coil (640cf0515 / 31098557), it was impeded in the introducer sheath and could not be pushed / introduced into the microcatheter.It was observed that the coil was prematurely detached in the microcatheter; the coil was detached prematurely from the delivery system.A new coil was used as replacement with the original concomitant microcatheter (unspecified brand) to complete the procedure.There was no report of any negative patient impact.A photo was included in the complaint.On 21-mar-2024, additional information was received.Per the information, the procedure was targeting a right posterior communicating artery aneurysm.The embolic coil did detach at the detachment zone on the device positioning unit.The information indicated that the coil did become separated into two or more pieces.The event did not result in any reduced / restricted blood flow.The microcatheter used was a competitor brand; a continuous flush was maintained through the microcatheter.The replacement coil was another 5mm x 15cm orbit galaxy complex fill coil (640cf0515).There was no delay in the procedure as a result of the reported issue.On 26-mar-2024, additional information was received.The clarifying additional information indicated that the coil prematurely detached and became separated in to two or more pieces.

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).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.The product analysis team reviewed the photo included in the complaint.The review is documented below.[photo review]: the photo that was included in the complaint shows the detached coil on the top of a surgery table, no apparent damages or separations can be appreciated due to the resolution / distance of the picture.The rest of the device is not observed in the picture and cannot be evaluated.A review of manufacturing documentation associated with this lot (31098557) 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.The issue regarding a coil being prematurely detached in the microcatheter was confirmed based on the detached condition noted on the coil.However, the impeded condition reported and the issue regarding a coil being separated into two or more pieces cannot be evaluated since a dimensional analysis needs to be performed and the coil needs to be inspected through a microscope.This investigation was performed based only on the photo provided.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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 report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 5mm x 15cm orbit galaxy complex fill coil was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The introducer was not returned for evaluation.The device was inspected under the microscope.Under magnification, it was observed that the embolic coil was severely stretched and broken on the proximal portion.It was noted that the headpiece remained attached to the gripper, which indicates that the coil was mechanically detached from the unit.The reported issue regarding the premature detachment of the coil was confirmed since the coil was found no longer attached to the delivery system and broken, based on this condition the issue regarding a coil being separated into two or more pieces can be confirmed.However, no damages were found on the device which indicates the detachment occurred prematurely as a result of a device failure.According to the risk documentation, premature detachment of the embolic coil assembly from the delivery system is a potential failure that can occur during embolic coil placement due to manipulation of the system against resistance which can result in the coil being stretched.It is possible that other clinical and procedural factors not described in this complaint may have contributed to the reported failure.The issue reported regarding the embolic coil being impeded in the introducer sheath could not be evaluated through functional testing since the introducer was not returned for evaluation.However based on the stretched condition of the coil is suggested that excessive force had been applied to the device during the advancing/retracting of the system in an attempt to overcome the difficulties experienced which ultimately result in the coil breakage.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.A review of manufacturing documentation associated with this lot (31098557) 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) contains the following precaution: 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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on (b)(6) 2024.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 5X15
• 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: 19016411
• MDR Text Key: 339238075
• Report Number: 3008114965-2024-00329
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030300
• UDI-Public: 10886704030300
• 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
• Report Date: 04/26/2024

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: 640CF0515
• Device Lot Number: 31098557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2023
• 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: MICROCATHETER (UNSPECIFIED BRAND)