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

Catalog Number 640CX0306

Device Problem Failure to Advance (2524)

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

Event Date 06/02/2023

Event Type  malfunction  

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.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 complex xtrasoft coil was received contained in the decontamination pouch.Visual inspection was performed.The hypo-tube (delivery tube) was observed broken into two (2) parts.No other damage was noted in the device components.The device was inspected under microscopic magnification, and the embolic coil was found with a knot condition in the distal portion; however, it was found to be in good normal conditions (i.E., no elongations, kinks, or non-concentric loops were noted); this remains partially inside of the introducer, it was still attached to the gripper.The condition found in the hypo-tube was not originally reported in the event, and the exact time when this condition occurred could not be determined.It is possible that force may have inadvertently been applied during the maneuvering of the coil, which resulted in the broken condition found in the hypo-tube.The condition previously described precluded proper testing, and based on the information provided, there is no relationship between the hypo-tube breakage and the coil becoming impeded in the microcatheter.With the evidence available at this time, the customer complaint cannot be evaluated.According to the risk documentation, delivery tube / embolic coil not pushing through the microcatheter is a potential issue that can occur during coil placement due to 1) excessively tortuous anatomy; or 2) clot formation in the microcatheter.With the limited information available, the root cause remains speculative, however, there is no indication that the issues encountered during the procedure are a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30592328) 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.Devices undergo 100% inspection at different points along the manufacturing process to prevent device damages from leaving the facility.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: ¿ 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.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, the physician opened the packaging of the 150cm x 5cm prowler select plus microcatheter (606s255x / 30979131) for inspection and observed that the microcatheter shaft was kinked / bent.The physician switched to an sl-10® microcatheter (stryker) to use for the procedure.It was reported that the complaint coil, an 3mm x 6cm orbit galaxy complex xtrasoft (640cx0306 / 30592328) was impeded in this replacement microcatheter and could not pass through.A continuous flush had been maintained through the microcatheter; nothing was noted to be obstructing the microcatheter.After making several attempts, the coil was still impeded in the microcatheter, the physician retracted the coil and replaced it with a new coil to complete the procedure using the same sl-10® microcatheter.There was no report of any negative impact to the patient.The complaint device was returned for evaluation and analysis.The product investigation completed on 28-jul-2023.Based on the completed product investigation, this event has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction".

• Brand Name: OG CMPLX XTRASOFT 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: 17420698
• MDR Text Key: 320778110
• Report Number: 3008114965-2023-00544
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030591
• UDI-Public: 10886704030591
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 640CX0306
• Device Lot Number: 30592328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2021
• 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)