MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MSPHERE 10 PLAT 4MMX7.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	SPH100400-20
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2021
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).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.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a coil embolization, a msphere 10 plat 4mmx7.5cm coil (sph10040020, 459685) couldn¿t be detached.The physician switched to another new one to complete the procedure.There was no injury reported.
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.A non-sterile unit msphere 10 plat 4mmx7.5cm was received inside of a pouch.The device was visually inspected, and it was found in good normal conditions, no damages or anomalies were observed during the visual inspection.A microscopic inspection was performed, and it was found that the embolic coil is in good normal conditions, no damages or anomalies were observed during the microscopic inspection.The resistance of the device msphere 10 plat 4mmx7.5cm (pi-16316291047707986) was measured with multimeter.Resistance measured approximately 53.2 o, which is in of the specification range.Also, the device was connected to detachment control box dcb2000500 (dcb) with a complaint enpower control cable lab sample, and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed and the embolic coil was detached without problem, the customer complaint was not confirmed.A manufacturing record evaluation (mre) was performed for the finished device l10045 number, and no non-conformances related to the reported complaint condition were identified.Cerenovus conducted visual inspection, microscopic inspection, and a functional test.During the visual and microscopic analysis of the device, it was noted that the device has no damages or anomalies.The resistance of the device msphere 10 plat 4mmx7.5cm (pi-16316291047707986) was measured with multimeter.The measured resistance is within the specification range between.Also, the device was connected to detachment control box dcb2000500 (dcb) with a complaint enpower control cable lab sample, and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed and the embolic coil was detached without problem.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.No functionality issues were observed on the device.
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: as reported by the field, during a coil embolization, a msphere 10 plat 4mmx7.5cm coil (sph10040020, 459685) couldn¿t be detached.The physician switched to another new one to complete the procedure.There was no injury reported.No additional information is available.A non-sterile unit msphere 10 plat 4mmx7.5cm was received inside of a pouch.The device was visually inspected, and it was found in good normal conditions, no damages or anomalies were observed during the visual inspection.A microscopic inspection was performed, and it was found that the embolic coil is in good normal conditions, no damages or anomalies were observed during the microscopic inspection.The resistance of the device msphere 10 plat 4mmx7.5cm (pi-16316291047707986) was measured with multimeter.Resistance measured approximately 53.2 o, which is in of the specification range.Also, the device was connected to detachment control box dcb2000500 (dcb) with a complaint enpower control cable lab sample, and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed and the embolic coil was detached without problem, the customer complaint was not confirmed.A manufacturing record evaluation (mre) was performed for the finished device l10045 number, and no non-conformances related to the reported complaint condition were identified.Cerenovus conducted a visual inspection, microscopic inspection, and a functional test.During the visual and microscopic analysis of the device, it was noted that the device has no damages or anomalies.The resistance of the device msphere 10 plat 4mmx7.5cm (pi-16316291047707986) was measured with multimeter.The measured resistance is within the specification range between.Also, the device was connected to detachment control box dcb2000500 (dcb) with a complaint enpower control cable lab sample, and the power was turned on.The system ready light was illuminating.Then, the detach button was pressed and the embolic coil was detached without problem.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Although no functionality issues were observed on the device, the instructions for use (ifu) do contain the following recommendations: verify that the microcoil delivery system is fully connected, and no faults are indicated on the dcb.If a fault exists, reseat all connections between the dpu, the dcb, and the connecting cable.If a fault still persists, replace the connecting cable.If this does not correct the error, replace the dcb.If the microcoil delivery system still continues to have a fault, retrieve the microcoil as described in the following section, re sheathing the microcoil system, and replace with a new microcoil system.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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: MSPHERE 10 PLAT 4MMX7.5CM
• 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. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12568476
• Report Number: 3008114965-2021-00491
• Device Sequence Number: 3419915
• Product Code: KRD
• UDI-Device Identifier: 00878528003540
• UDI-Public: 00878528003540
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002056
• 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,Followup
• Report Date (Section B): 11/29/2021

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: 09/30/2022
• Device Model Number: SPH100400-20
• Device Catalogue Number: SPH10040020
• Device Lot Number: 459685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2021
• Supplement Date Received by Manufacturer: 10/07/2021; 11/29/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 10/27/2021; 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2017
• 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