MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR140306
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2020
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, ethnicity, and medical history were not provided.Procode is krd/hcg.The name, phone and email address of the initial reporter are not available / reported.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.A review of manufacturing documentation associated with this lot (l14591) presented no issues during the manufacturing, or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture, or inspection.All product rejected during manufacturing was identified as scrap, and properly accounted for.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 during the procedure, the 3mm x 6cm micrusframe 14 coil (mfr140306 / l14591) was implanted, and ready to be detached.However, when the detachment button was pressed several times, the coil did not detach.The physician did not replace the enpower control cable, or the detachment control box; only the coil was removed and replaced.The new replacement coil detached without any issue.The procedure was resumed.There was no report of any patient adverse event, or complication.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr is to include the additional event information received on 12/21/2020.[additional event information]: the healthcare professional reported that during the procedure, the 3mm x 6cm micrusframe 14 coil (mfr140306 / l14591) was implanted and ready to be detached.However, when the detachment button was pressed several times, the coil did not detach.The physician did not replace the enpower control cable or the detachment control box; only the coil was removed and replaced.The new replacement coil detached without any issue.The procedure was resumed.There was no report of any patient adverse event or complication.Additional information was received indicating that the procedure was targeting the lesion on the inferior mesenteric artery.All the connections on the coil and connecting cable appeared to fit properly without application of excessive force.The reported event did not result in a clinically significant delay in the procedure.E.1: the initial reporter phone: (b)(6).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 that the product was received by the product analysis lab on 12/4/2020.The return product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This supplemental report will also include correction to the codes in section h.6.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.In the initial report, the following sections were left blank by mistake: h.6: health effect - impact code.H.6: health effect - clinical code.H.6: medical device problem code.In this supplemental report, the codes have been added to these fields.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during the procedure, the 3mm x 6cm micrusframe 14 coil (mfr140306 / l14591) was implanted and ready to be detached.However, when the detachment button was pressed several times, the coil did not detach.The physician did not replace the enpower control cable or the detachment control box; only the coil was removed and replaced.The new replacement coil detached without any issue.The procedure was resumed.There was no report of any patient adverse event or complication.On (b)(6) 2020, the complaint device was received in the product analysis lab.The investigation has been completed.The documented findings are included below.Investigation summary: the non-sterile 3mm x 6cm micrusframe 14 coil was received contained in a pouch.Visual inspection was performed.The marker band was found at 41cm from the hub; this is within specification.The device positioning unit (dpu) was observed kinked at 19cm and 90cm from the proximal end.It was also observed that covering around the electrical wires was peeling and exposing the wires.No other damages were observed.The complaint device underwent a microscopic inspection.The embolic coil was observed damaged.Functional analysis: the resistance of the device was measured with a multimeter.The initial resistance reading was 0 o, which demonstrated a loss of electrical continuity along the device.The device was then connected to a lab sample detachment control box dcb2000500 with a lab sample enpower control cable; the power was turned on.The system ready light did not illuminate.This is likely due to the absence of electrical continuity through the device due to the peeling cover around the wires as observed during the visual inspection.A review of manufacturing documentation associated with this lot (l14591) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint documented that the 3mm x 6cm micrusframe 14 coil was implanted but failed to detach during the procedure.The detachment button was pressed several times, but the coil failed to detach.The physician did not replace the enpower control cable, instead the coil was replaced, and the replacement coil detached without issue.The reported issue related to the failure of the complaint coil to detach was confirmed.The cover around the electrical wires on the returned device was peeling and exposing the wires; when the device was connected to the multimeter, there was no electrical continuity observed with the resistance reading of 0 o.The system ready light did not illuminate when the complaint coil was connected to the lab samples dcb and enpower control cable.Without electrical continuity, the coil would not be able to detach when the detachment cycle is initiated.The cause of the peeling cover cannot be conclusively determined, however, the complaint documented that the detachment button was pressed several times during the procedure in attempt to detach the coil.This may have been a contributing factor the observed peeling cover.The condition of the coil as observed under the microscope is likely due to procedural handling of the device, where force may have been inadvertently applied.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Devices undergo 100% inspection at final assembly for the condition of the product.Thus, it is not likely that the 3mm x 6cm micrusframe 14 coil left the manufacturing facility in the condition that was observed on the returned complaint device.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: MICRUSFRAME14 3MM X 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: 10820210
• Report Number: 3008114965-2020-00482
• Device Sequence Number: 4177737
• Product Code: KRD
• UDI-Device Identifier: 10886704077961
• UDI-Public: 10886704077961
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/22/2020

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: 12/31/2021
• Device Model Number: MFR140306
• Device Catalogue Number: MFR140306
• Device Lot Number: L14591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/04/2020; 12/08/2020; 12/21/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/05/2020; 12/09/2020; 12/21/2020
• 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: DETACH CONTROL BX DCB01.; ENPOWER CONTROL CABLE.