MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0408
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).A visual analysis was performed on the photo accompanied with the complaint file.The embolic coil is noted to be detached from the rest of the device; however, no damages could be noted on the embolic coil due to the resolution of the photo.The hypotube appears to be in a kinked condition at three different locations.No other damages or anomalies were observed on the photo.A manufacturing record evaluation (mre) was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed since the embolic coil can be observed separated from the gripper.This investigation was performed based only on the photo provided.No further evaluation will be performed since the device said to be involved was reported as discarded.Should new information becomes available at a later date, this investigation will be assessed and updated as applicable.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.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 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.
Event or Problem Description
As reported by the field, during a coil embolization of an aneurysm at the left posterior communicating artery, a 4x8 orbit galaxy xtrasoft coil (640cx0408, 30620249) prematurely detached.The aneurysm size: length: 3.7 mm, width: 3.1 mm.The physician pushed coil out for inspection and observed it detached.The coil was not used in the patient.A new coil was used to complete the surgery.There was no patient injury report.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Section b5: additional information received indicated that there was no damage noted before removing the device from packaging, during removal from package or while prepping the device.The device was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the device.No excessive force was used at any time while handling the device.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during a coil embolization of an aneurysm at the left posterior communicating artery, a 4x8 orbit galaxy xtrasoft coil (640cx0408, 30620249) prematurely detached.The aneurysm size: length: 3.7 mm, width: 3.1 mm.The physician pushed coil out for inspection and observed it detached.The coil was not used in the patient.A new coil was used to complete the surgery.There was no patient injury report.Additional information received indicated that there was no damage noted before removing the device from packaging, during removal from package or while prepping the device.The device was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the device.No excessive force was used at any time while handling the device.A visual analysis was performed on the photo accompanied with the complaint file.The embolic coil is noted to be detached from the rest of the device; however, no damages could be noted on the embolic coil due to the resolution of the photo.The hypotube appears to be in a kinked condition at three different locations.No other damages or anomalies were observed on the photo.A manufacturing record evaluation (mre) was performed, and no non-conformances related to the reported complaint condition were identified.The customer complaint was confirmed since the embolic coil can be observed separated from the gripper.This investigation was performed based only on the photo provided.No further evaluation will be performed since the device said to be involved was reported as discarded.It is possible that the handling and prepping of the device may have contributed to the reported failure.Should new information become available at a later date, this investigation will be assessed and updated as applicable.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 4X8
• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14249819
• Report Number: 3008114965-2022-00306
• Device Sequence Number: 20087471
• Product Code: KRD
• UDI-Device Identifier: 10886704030638
• UDI-Public: 10886704030638
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 06/30/2023
• Device Model Number: 640CX0408
• Device Catalogue Number: 640CX0408
• Device Lot Number: 30620249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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
• Patient Sex: Unknown