MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSPHERE 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CSP10030030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Three attempts to obtain additional information were unsuccessful.No additional information could be obtained.Conclusion: the micrusphere was returned for analysis.The unidentified detachment control box (dcb), connecting cable and microcatheter was not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The detachment fiber was intact, undamaged, and did not receive heat and melt.The device positioning unit (dpu) failed electrical testing with resistance at 0.0 ohms (range 48.5/56.0)and the lab sample enpower dcb and cable systems ready green light failed to.No manufacturing defects were found.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the coils non-detachment was confirmed.While the root cause of the coils non-detachment could not be determined, the evidence as received highly suggests the most likely contributing factor to the coils non-detachment may have been due to a fracture of the solder joint connection inside the resistive heating coil or from wiring damage.The circumstances of how and when the wiring damage occurred cannot be determined as all microcoil systems are tested prior to final packaging.In addition, without the identification or the return of the complete detachment system and the microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization, the micrusphere (csp10030030/ c38744) could not be detached.They withdrew the coil and used a new coil to complete the procedure.There was no report of patient injury.Multiple attempts to obtain additional information were unsuccessful.
Additional Manufacturer Narrative
There is no new information to report at this time.The report is being submitted to correct the sequential numbering of the follow-up reports per fda's request.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
Additional information was received on 10/20/1016: the same enpower detachment control box and connecting cable were used to complete the procedure.A pre-deployment electrical check had been performed.A low battery light or a fault like was not seen.The green system ready light illuminated, but during the detachment cycle, the detachment light did not illuminate and the audible signal did not beep.All connections appeared to fit properly without application of excessive force.The entire coil was removed without need for additional intervention.There was no resistance between the coil and microcatheter and the same microcatheter was used to complete the procedure.When the coil was removed, it did not appear damaged (i.E.Stretched, kinked, separated, prematurely detached).There was no report of a clinically significant delay in the procedure.No further information could be obtained, including patient age, gender and medical history or intended procedure/target vessel.This new information does not change the mdr reportability, coding or conclusion of the event.

• Brand Name: MICRUSPHERE 10 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6031748
• Report Number: 2954740-2016-00242
• Device Sequence Number: 544359
• Product Code: HCG
• UDI-Device Identifier: 00878528001027
• UDI-Public: (01)00878528001027(17)200930(10)C38744
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K0022420
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2016

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: 09/30/2020
• Device Catalogue Number: CSP10030030
• Device Lot Number: C38744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 10/14/2016
• Supplement Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown