MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 12MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR181240
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.The initial reporter phone of the is 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 (l13777) 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 during the procedure, the 12mm x 40cm micrusframe 18 coil (mfr181240 / l13777) would not detach.The physician attempted to detach the coil using two different enpower control cables and two enpower detachment control boxes.The physician tried pulling the coil through the microcatheter to abort but the coil became detached when it was being retracted through the microcatheter.The physician opted to use stryker coils for the remainder of the procedure.There was no restriction or reduction of blood flow as a result of the reported event.No evidence of thrombosis was reported.It is not known if the portion of the coil that came out of the pusher wire was still attached to the delivery system.The enpower control cables were reported as not functioning.The enpower detachment control boxes had the system fault light illuminated red at first, but then on both boxes, the lights did turn green.A pre-deployment electrical check was performed.The green system ready light did illuminate, and the audible beep was heard during the detachment cycle.The physician switched to stryker coils to complete the procedure.The event did not result in any clinically significant delay in the procedure.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 submission is to report that the product analysis lab received the returned complaint device on (b)(6) 2020.The returned product underwent evaluation and analysis.[conclusion]: the healthcare professional reported during the procedure, the 12mm x 40cm micrusframe 18 coil (mfr181240 / l13777) would not detach.The physician attempted to detach the coil using two different enpower control cables and two enpower detachment control boxes.The physician tried pulling the coil through the microcatheter to abort but the coil became detached when it was being retracted through the microcatheter.The physician opted to use stryker coils for the remainder of the procedure.There was no restriction or reduction of blood flow as a result of the reported event.No evidence of thrombosis was reported.It is not known if the portion of the coil that came out of the pusher wire was still attached to the delivery system.The enpower control cables were reported as not functioning.The enpower detachment control boxes had the system fault light illuminated red at first, but then on both boxes, the lights did turn green.A pre-deployment electrical check was performed.The green system ready light did illuminate, and the audible beep was heard during the detachment cycle.The physician switched to stryker coils to complete the procedure.The event did not result in any clinically significant delay in the procedure.There was no report of any patient adverse event or complication.The complaint coil was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: the non-sterile 12mm x 40cm micrusframe 18 coil was received contained in a pouch.Visual inspection was performed.Only the embolic coil was returned for evaluation.The embolic coil was microscopically inspected and was observed in stretched condition.The condition of the returned embolic coil also suggests that it was mechanically detached from the rest of the device.Functional testing was precluded as only the embolic coil was returned and it appeared to have been mechanically detached from the device.A review of manufacturing documentation associated with this lot (l13777) 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 12mm x 40cm micrusframe 18 coil would not detach during the procedure when the physician attempted to detach it using two different enpower control cables with two enpower detachment control boxes; during the attempt to pull the coil through the microcatheter to abort the detachment attempt, the coil became detached as it was being retracted through the concomitant microcatheter.The issue related to the failure of the embolic coil to detach during the procedure using different enpower control cables and enpower dcbs could not be confirmed through functional analysis as the coil was returned already mechanically detached.The enpower control cables and detachment boxes were not available to be returned for analyses; it is possible that there were issues with one of these devices that resulted in the coil not properly detaching during the procedure.The issue with the premature detachment during removal was confirmed; only the embolic coil was received for evaluation.Based on the microscopic inspection, the embolic coil appeared to have been mechanically detached from the device.It was also in stretched condition.The stretched condition of the embolic coil and the appearance of being mechanically detached is related to the reported issue with the several attempts to detach the coil; excessive force may have inadvertently been applied during the coil withdrawl into the microcatheter to abort the detachment attempt.Coil stretching is a known potential issue associated with the use of this device.The ifu provides proper handling instructions for the device to prevent such issue from occurring.Stretching can occur during attempts to withdrawal the coil against resistance.The stretched condition of the embolic coil was not originally reported with the complaint.The exact cause of the observed stretched condition could not be conclusively determined; however, it may have been during the attempt to pull the coil through the concomitant microcatheter that it became stretched due force that was inadvertently applied.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.In addition, devices undergo 100% inspection at final assembly for the condition of the embolic coil.Thus, it is not likely that the 12mm x 40cm micrusframe 18 coil left the manufacturing facility with the embolic coil in a stretched condition as observed on the returned coil component.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 of failure to detach was related to a manufacturing or design issue, no corrective actions will be taken at this time.Updated sections: d.10, g.4.G.7, h.2, h.3, h.6, and h.10.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: MICRUSFRAME18 12MM X 40CM
• 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: 10672094
• Report Number: 3008114965-2020-00432
• Device Sequence Number: 2991432
• Product Code: KRD
• UDI-Device Identifier: 10886704078098
• UDI-Public: 10886704078098
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 08/31/2021
• Device Model Number: MFR181240
• Device Catalogue Number: MFR181240
• Device Lot Number: L13777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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: UNK CONNECTING CABLE.; UNK DETACHMENT CONTROL BOX.