MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MSPHERE 10 CERE, 3.5MMX6.6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	CSP10035030
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2019
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).Manufacturing site name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)) the device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.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 a healthcare professional, during a coil embolization, a 3.5mmx6.6cm msphere 10 cere coil (csp10035030, s14654) couldn¿t be detached.The physician found the problem with green light not working and changed the detached box and connected the line, tried again and still failed.The device was removed from the patient without additional intervention.The procedure was completed successfully by using a competitor¿s coil.No patient injury was reported.The complaint coil was not implanted, it was pulled back into the introducer.There was no significant prolongation of the procedure due to the event.A pre-deployment electrical testing was performed and there were no failures in this process.The same dcb was used with subsequent coils and the same cable was used with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The coil was not stretched or damaged when removed from the patient.The device was inspected prior to use and no damage was noted.The device was used and prepped as per the instructions for use (ifu).Adequate flush was maintained through the devices.
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 concluson: as reported by a healthcare professional, during a coil embolization, a 3.5mmx6.6cm msphere 10 cere coil (csp10035030, s14654) couldn¿t be detached.The physician found the problem with green light not working and changed the detached box and connected the line, tried again and still failed.The device was removed from the patient without additional intervention.The procedure was completed successfully by using a competitor¿s coil.No patient injury was reported.The complaint coil was not implanted, it was pulled back into the introducer.There was no significant prolongation of the procedure due to the event.A pre-deployment electrical testing was performed and there were no failures in this process.The same dcb was used with subsequent coils and the same cable was used with subsequent coils.The coil was still attached to the coil delivery system when removed from the patient.The coil was not stretched or damaged when removed from the patient.The device was inspected prior to use and no damage was noted.The device was used and prepped as per the instructions for use (ifu).Adequate flush was maintained through the devices.A non-sterile unit msphere 10 cere, 3.5mmx6.6cm was received inside of a pouch.The hub was inspected, and no damages was noted on it.The dpu was inspected and it was found kinked at 36.5 cm and 42 cm from proximal.The re-sheathing tool was inspected, and it was found in good normal conditions.The introducer was inspected, and it was found without damages, however it was found with dry blood residues inside it.The v-notch was inspected under microscope and it was found in good normal conditions.The rh, the articulation joint and the embolic coil were inspected under microscope and they were found in good normal conditions, however they were stuck inside the introducer by dry blood residues.As well as the it was found no heated.The resistance of the device msphere 10 cere, 3.5mmx6.6cm was measured with multimeter.Resistance was initially measured, and it was found within specification range.Also, the device was connected to detachment control box dcb00000500 (dcb) with an enpower control cable lab sample and the power was turned on.The system ready light was illuminating.However, the detach cycle could not be performed due the embolic coil is stuck inside the introducer by dry blood residues.A manufacturing record evaluation was performed for the finished device s14654 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - failure to detach¿ could not be evaluated due the embolic coil was found stuck by dry blood residues inside the introducer.However, the device electrical parameters were found within specification and the lab sample detachment box was illuminated while trying to perform the functional test.The dry residues could be related to insufficient flushing, since the device was used during the procedure, however this cannot be conclusively determined.The kinked condition from dpu may have be appearing to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggest that the failure reported by the costumer could be related to the manufacturing process.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.Assignment of root cause for the event remains speculative and inconclusive.However, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MSPHERE 10 CERE, 3.5MMX6.6CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9368959
• Report Number: 3008114965-2019-01254
• Device Sequence Number: 2325664
• Product Code: HCG
• UDI-Device Identifier: 00878528001034
• UDI-Public: 00878528001034
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K0022420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2019

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: 06/30/2022
• Device Catalogue Number: CSP10035030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DETACHABLE CONTROL BOX