MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X4; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX0304
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Additional 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.Section h.3: 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.The product analysis team reviewed the two photos included in the complaint.The review is documented below.[photo review]: two photos of the coil were included in the complaint.It is observed that the coil is outside of the introducer.The embolic coil component has a malformation in its shape.It cannot be determined from the photo if the embolic coil has some damage that contributed to this.The rest of the device is not on the photos.A review of manufacturing documentation associated with this lot (31025931) 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.The reported issue regarding the irregular shape of the coil was confirmed since the embolic coil could be noted with a malformation in its regular shape; the root cause remains unknown since no damages were noted on it in the provided pictures.A microscopic evaluation will be performed once the device returns for analysis.If the product is received after this investigation, an assessment will be performed as per the conditions of the device returned.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 a patient presenting with a 3mm basilar bifurcation aneurysm underwent an endovascular embolization procedure.During the procedure, the first coil used to fill the aneurysm was a 3mm x 4cm orbit galaxy complex xtrasoft (640cx0304 / 31025931).It was reported that the coil was unable to ¿rotate randomly and the shape of the coil was not ideal.¿ the physician retracted the coil and switched to a competitor brand to complete the procedure; the microcatheter (unspecified brand) was not replaced.There was no report of any negative patient impact.Two photos of the coil were included in the complaint.On 11-sep-2023, additional information was received from the cerenovus sales representative.The information indicated that the target aneurysm was unruptured.The microcatheter used was an echelon¿ 10 microcatheter (medtronic).There was no patient injury or patient complication as a result of the reported issue.There was no clinically significant delay in the procedure.
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab 06-oct-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.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.
Additional Manufacturer Narrative
Manufacturer¿s ref.No:(b)(4).The purpose of this mdr submission is to report the investigation finding of the returned device.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 3mm x 4cm orbit galaxy complex xtrasoft coil was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil was observed to be visibly damaged, which was not observed in the photos included in the complaint.Microscopic inspection was performed.Under magnification, the coil was confirmed to be stretched and kinked.The shape of the complaint coil was analyzed and it appeared to have random loops that are consistent with the complex coil; however, this assessment was made based on the visualization of the extended coil.The coil could not be retracted into the introducer due to the stretched and kinked conditions observed.Therefore, it could not be re-deployed to observe the shape formed with the adequate tool.A review of manufacturing documentation associated with this lot (31025931) 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.The issue reported that the coil could not ¿rotate randomly and the shape of the coil was not ideal.¿ could not be confirmed since the damages observed on the returned coil precluded proper evaluation.The coil kinking and stretching were not originally reported in the complaint and were not observed in the photo provided, which indicates that such damages occurred during posterior manipulation (i.E.During shipping and decontamination).These damages are not considered a device failure and therefore not a contributing factor to the issue reported.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.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 3X4
• 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: 17795555
• Report Number: 3008114965-2023-00651
• Device Sequence Number: 6731284
• Product Code: KRD
• UDI-Device Identifier: 10886704030584
• UDI-Public: 10886704030584
• 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,Followup,Followup
• Report Date (Section B): 10/16/2023

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: 02/28/2025
• Device Catalogue Number: 640CX0304
• Device Lot Number: 31025931
• 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: 09/04/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 10/13/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/06/2023; 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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