MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 10X30; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 640CF1030

Device Problem Device Difficult to Setup or Prepare (1487)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth, age, weight, race, and ethnicity were not provided.Procode is krd/hcg.The initial reporter phone: (b)(6).The initial reporter email address is not available / reported.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure targeting a wide neck basilar top aneurysm, both coils, a 10mm x 30cm orbit galaxy complex fill coil (640cf1030 / 30305849) and a 8mm x 30cm orbit galaxy complex frame coil (640cr0830 / 30334344) could not be resheathed.The coils were removed and replaced.The reported issue resulted in a 15-minute procedure delay, but the procedure was successfully completed with a good patient outcome.Additional information was received.The information indicated that the microcatheter used was a 150cmx5cm, 2 markers, 45tip prowler select lpes from lot 30342894.There was continuous flush maintained through the microcatheter.There was no damage noted to the sheath introducers.There was no report of any resistance at any time during the advancement of the coils through the microcatheter.The procedure also employed a 4mm x 39mm enterprise 2 vascular reconstruction device.The concomitant microcatheter was not repositioned over the coil when the cil was deployed.There was a one-to-one relationship between the coil and the delivery system and it was verified with fluoroscopy prior to repositioning.The microcatheter was not removed from the target position.No additional intervention was required.The reported issue did not result in any restriction / reduction in blood flow.The procedure was completed using another coil.No patient adverse event nor complication was reported.The device was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 10mm x 30cm orbit galaxy complex fill coil was received contained in a pouch.Visual inspection was performed.The embolic coil was observed tangled with the device.The hypotube was also observed to be severely kinked.No other damages nor anomalies were observed during the visual inspection.Microscopic inspection: under microscopic magnification, the embolic coil component is observed to be in severely stretched condition in addition to being tangled with the rest of the complaint device.Functional test could not be performed.The device could not be resheathed due to the severely kinked condition of the hypotube.A review of manufacturing documentation associated with this lot (30305849) 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.The complaint documented that during the procedure the 10mm x 30cm orbit galaxy complex fill coil was one of the two coils used; both coils could not be resheathed.With the information available and based on the observed condition of the returned complaint device, the reported issue was confirmed.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendation: failure to hold the tab and the delivery tube could result in the delivery tube moving out of the coil introducer and exposing the flexible section of the delivery tube or exposing the coil.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 issue 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.The exact cause of the stretched condition of the coil cannot be conclusively determined; however, it is possible that during the attempt to resheath the coil, some force was inadvertently applied to the device which resulted in the coil becoming stretched and likely contributed to the kinked condition observed on the hypotube of the device.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 10mm x 30cm orbit galaxy complex fill coil left the manufacturing facility with the embolic coil in stretched condition and the hypotube in kinked condition.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.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 Description

The healthcare professional reported that during an endovascular embolization procedure targeting a wide neck basilar top aneurysm, both coils, a 10mm x 30cm orbit galaxy complex fill coil (640cf1030 / 30305849) and a 8mm x 30cm orbit galaxy complex frame coil (640cr0830 / 30334344) could not be resheathed.The coils were removed and replaced.The reported issue resulted in a 15-minute procedure delay, but the procedure was successfully completed with a good patient outcome.Additional information was received.The information indicated that the microcatheter used was a 150cmx5cm, 2 markers, 45tip prowler select lpes from lot 30342894.There was continuous flush maintained through the microcatheter.There was no damage noted to the sheath introducers.There was no report of any resistance at any time during the advancement of the coils through the microcatheter.The procedure also employed a 4mm x 39mm enterprise 2 vascular reconstruction device.The concomitant microcatheter was not repositioned over the coil when the cil was deployed.There was a one-to-one relationship between the coil and the delivery system and it was verified with fluoroscopy prior to repositioning.The microcatheter was not removed from the target position.No additional intervention was required.The reported issue did not result in any restriction / reduction in blood flow.The procedure was completed using another coil.No patient adverse event nor complication was reported.The complaint devices were returned for evaluation and analysis.During the microscopic inspection of the 10mm x 30cm orbit galaxy complex fill coil (640cf1030 / 30305849), the embolic coil was observed to be severely stretched and tangled with the rest of the device.Based on the product analysis on 14 dec 2021, this event has been deemed mdr reportable as a ¿malfunction.¿.

• Brand Name: OG TDL CMPLX FILL COIL 10X30
• 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): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-868
• MDR Report Key: 13006718
• MDR Text Key: 290282178
• Report Number: 3008114965-2021-00668
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030416
• UDI-Public: 10886704030416
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 12/14/2021

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 Expiration Date: 09/30/2021
• Device Model Number: 640CF1030
• Device Catalogue Number: 640CF1030
• Device Lot Number: 30305849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2019
• 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
• Patient Sex: Female