MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0308
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during an endovascular embolization procedure, the complaint coil, a 3mm x 8cm orbit galaxy complex xtrasoft coil (640cx0308 / 30494093) was not framing the target successfully.The physician retracted the coil and replaced it with a new one to complete the procedure.The microcatheter was not replaced.Here was no report of any patient injury.On (b)(6) 2022, additional information was received.The information indicated that the lot number of complaint coil is (b)(4).The target lesion was on the middle cerebral artery (mca).There was no difficulty positioning the coil in the target site; there was difficulty in getting the coil to conform to the aneurysm wall.The information indicated that the coil could not be conformed to the aneurysm.When the coil was removed, it was still attached to the delivery system; it was not stretched nor damaged when it was removed.The complaint coil was the first coil used.It was used with the echelon¿ 10 microcatheter (medtronic), which was also used to complete the procedure.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).D.2b: procode is krd/hcg.The initial reporter phone: (b)(6) the initial reporter email address was not available / reported.[conclusion]: the healthcare professional reported that during an endovascular embolization procedure, the complaint coil, a 3mm x 8cm orbit galaxy complex xtrasoft coil (640cx0308 / 30494093) was not framing the target successfully.The physician retracted the coil and replaced it with a new one to complete the procedure.The microcatheter was not replaced.Here was no report of any patient injury.On (b)(6) 2023, additional information was received.The information indicated that the lot number of complaint coil is 30494093.The target lesion was on the middle cerebral artery (mca).There was no difficulty positioning the coil in the target site; there was difficulty in getting the coil to conform to the aneurysm wall.The information indicated that the coil could not be conformed to the aneurysm.When the coil was removed, it was still attached to the delivery system; it was not stretched nor damaged when it was removed.The complaint coil was the first coil used.It was used with the echelon¿ 10 microcatheter (medtronic), which was also used to complete the procedure.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30494093) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.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 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.

• Brand Name: OG CMPLX XTRASOFT COIL 3X8
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 15921602
• Report Number: 3008114965-2022-00776
• Device Sequence Number: 5398745
• Product Code: KRD
• UDI-Device Identifier: 10886704030607
• UDI-Public: 10886704030607
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/05/2022

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: 11/30/2022
• Device Model Number: 640CX0308
• Device Catalogue Number: 640CX0308
• Device Lot Number: 30494093
• 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: 11/24/2022
• Initial Report FDA Received Date: 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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: ECHELON¿ 10 MICROCATHETER (MEDTRONIC)
• Patient Sex: Unknown