MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 9X30; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CR0930
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.(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 and email address are not available / reported.The product was received in the product analysis lab on 17-aug-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.A review of manufacturing documentation associated with this lot (30706306) 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, the following coils were used: the hypotube of the first coil, a 9mm x 30mm orbit galaxy complex frame coil (640cr0930 / 30706306) reportedly broke while ¿pushing the coil through the catheter.¿ another coil, a 2mm x 2cm orbit galaxy complex xtrasoft coil (640cx0202 / 30868860) could not be resheathed.On 10-aug-2023, additional information received indicated that the procedure was targeting an aneurysm on the middle cerebral artery (mca).The hypotube of the 9mm x 30mm orbit galaxy complex frame coil (640cr0930 / 30706306) became kinked, then fractured into two while the coil was being pushed through the microcatheter.The 2mm x 2cm orbit galaxy complex xtrasoft coil (640cx0202 / 30868860) had positioning difficulty which prompted the reported failed attempt to resheath.There was resistance during the advancement of both coils through the microcatheter, the resistance was at the mid-shaft of the microcatheter.The information indicated that neck remodeling was not used.The microcatheter was left in place and the coils were replaced.The procedure was reported to have been successfully completed.Based on the additional information received on 10-aug-2023, the reported issue related to the 9mm x 30mm orbit galaxy complex frame coil (640cr0930 / 30706306) has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.
Additional Manufacturer Narrative
Manufacturer¿s ref.(b)(4).The purpose of this mdr submission, is to report the investigation finding of the returned device.This mdr submission also includes a correction to the initial reporter postal code.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 9mm x 30mm, orbit galaxy complex frame coil was received, contained in the decontamination pouch.Visual inspection was performed.The hypotube was observed, to be in broken condition.One kinked area was observed, at 141 cm from the proximal end.The embolic coil component was returned inside the introducer.The returned device was inspected under the microscope.Under magnification, the embolic coil was noted, to still be attached to the delivery system.It was observed, without any appearance of damages (i.E., no elongations, no kinks, no non-concentric loops were noted).The issues regarding a hypo-tube being kinked, broken and the resistance felt, during the advancement were confirmed, based on the documented above.The kinked and broken condition appearance of the returned device suggests, that it was subjected to excessive force to overcome the friction with the microcatheter.Factors not described in the event description, such as inadequate flush, may have contributed to the issue encountered, during the procedure.According to the risk documentation, resistance in microcatheter is a potential issue that can occur, during microcoil placement, due to excessively tortuous anatomy, which can result in the hypo-tube being kinked and subsequently broken.There is no indication, that the issue reported is a result of a defect inherently related to the device.A review of manufacturing documentation associated with this lot#: (30706306), 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 is multifactorial.The instructions for use (ifu) contains the following precautions: 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 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.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00616.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.Section e.1: initial reporter postal code: in the 3500a initial report.The initial reporter postal code was incorrectly documented as "(b)(6)".It has been corrected in this 3500a supplemental report.The correct postal code is (b)(6).

• Brand Name: OG TDL CMPLX FRAME COIL 9X30
• 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): 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 ; 303552-6892
• MDR Report Key: 17568499
• Report Number: 3008114965-2023-00568
• Device Sequence Number: 15126939
• Product Code: KRD
• UDI-Device Identifier: 10886704030461
• UDI-Public: 10886704030461
• 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
• Report Date (Section B): 08/24/2023

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: 11/30/2023
• Device Catalogue Number: 640CR0930
• Device Lot Number: 30706306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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
• Patient Sex: Unknown