MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0406
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by a healthcare professional that during an endovascular coil embolization in a male patient, a 3mm x 4cm orbit galaxy complex xtrasoft coil (640cx0304/30615573) was found to be prematurely detached when the package was opened, prior to use.The 4mm x 6cm orbit galaxy complex xtrasoft coil (640cx0406/30562629) became stretched during deployment of the coil in the mca, which required use of a snare for removal.The procedure was successfully completed with no patient injury.The surgery was delayed 10-20 minutes due to the event.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.(b)(6).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.This information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report number is 3008114965-2022-00145.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: it was reported by a healthcare professional that during an endovascular coil embolization in a male patient, a 3mm x 4cm orbit galaxy complex xtrasoft coil (640cx0304/30615573) was found to be prematurely detached when the package was opened, prior to use.The 4mm x 6cm orbit galaxy complex xtrasoft coil (640cx0406/30562629) became stretched during deployment of the coil in the mca, which required use of a snare for removal.The procedure was successfully completed with no patient injury.The surgery was delayed 10-20 minutes due to the event.A non-sterile og cmplx xtra soft coil 3x4 was received inside of a pouch.The embolic coil component was outside of the introducer and severely stretched, the blue stretch resistant fiber was snapped off.No other damages could be noted on the rest of the components.A manufacturing record evaluation was performed for the finished device [30562629] number, and no non-conformance's related to the reported complaint condition were identified.The device was returned to cerenovus for further evaluation.Upon arrival, it was noted that the embolic coil component was outside of the introducer and severely stretched, the blue stretch resistant fiber was snapped off.No other damages could be noted on the rest of the components.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.The customer complaint was confirmed based on the finding noted on the embolic coil component, however, no contributing factors could be identified from the device.Since the concomitant microcatheter (prowler select plus) was not facilitated in the lab, no further evaluation could be conducted.A manufacturing record evaluation was performed, and no non-conformance was found during the review.It should be noted that product failure could be caused by multiple factors.The instructions for use do contain the following precaution: ¿ 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.Coil unraveling/stretching is classified as an mdr reportable malfunction as this failure could cause coil premature detachment, separation, herniation into parent vessel, with the potential for non-target site embolization, ischemia or infarct.In this case, the event required use of a snare to preclude patient complications, such as non-target site embolization, ischemia, or infarct.The file will be re-reviewed if additional information is received at a later date.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: OG CMPLX XTRASOFT COIL 4X6
• 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): 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 ; 9497898687
• MDR Report Key: 13595137
• Report Number: 3008114965-2022-00147
• Device Sequence Number: 20297719
• Product Code: KRD
• UDI-Device Identifier: 10886704030621
• UDI-Public: 10886704030621
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 03/31/2023
• Device Model Number: 640CX0406
• Device Catalogue Number: 640CX0406
• Device Lot Number: 30562629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 04/11/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: OG CMPLX XTRASOFT COIL 4X6; UNKPROWLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 75 KG