MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number MFR100517

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

Additional product codes: krd/hcg.Concomitant products: two enpower control cables (ecb00018200/ s13060 and ecb00018-00/ p11151).(b)(6).It was reported that the device would be returned for analysis; however, the device has not yet been returned.The customer name could not be provided.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during coil embolization of a 5mm ruptured anterior communicating artery aneurysm with subarachnoid hemorrhage, a micrusframe 10 coil (mfr100517/ s13059) could not be detached using two enpower control cables (ecb00018200/ s13060 and ecb00018-00/ p11151).The micrusframe 10 was selected for the first coil and pre-detachment check was performed.After creating the frame in the aneurysm, the coil was attempted to be detached, so the physician connected it to the connector, but the power light of the control box did not illuminate.The cable was replaced with another one, but the issue continued.The detachment button was pressed while using both cables, but there was no response.The coil was removed without any problem.The coil was replaced with another one.Competitors coils were used to complete the procedure.The procedure was successfully completed without further issues.However, due to the event it was delayed for 10 minutes.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The products will be returned for investigation.No further information was available.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, during coil embolization of a 5mm ruptured anterior communicating artery aneurysm with subarachnoid hemorrhage, a micrusframe 10 coil (mfr100517/ s13059) could not be detached using two enpower control cables (ecb00018200/ s13060 and ecb00018-00/ p11151).The micrusframe 10 was selected for the first coil and pre-detachment check was performed.After creating the frame in the aneurysm, the coil was attempted to be detached, so the physician connected it to the connector, but the power light of the control box did not illuminate.The cable was replaced with another one, but the issue continued.The detachment button was pressed while using both cables, but there was no response.The coil was removed without any problem.The coil was replaced with another one.Competitors coils were used to complete the procedure.The procedure was successfully completed without further issues.However, due to the event it was delayed for 10 minutes.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.No further information was available.As returned, the micrusframe10 embolic coil is advanced out of the introducer and tangled around the device positioning unit (dpu).The embolic coil was gently disentangled from the dpu.There is a severe kink in the dpu core wire approximately 70.5 cm from the proximal end.The ball tip is intact.There are no kinks or stretched sections on the embolic coil.The articulating joint is intact.The resistance heating (rh) coil did not receive heat and melt.The resistance of the device was measured.The resistance was overloaded, which is outside of the specification range of 48.5 ¿ 56.The device was connected to dcb2 (b)(4)with enpower connecting cable (b)(4) and the power was turned on.Neither the system ready light nor the system fault light illuminated.The embolic coil was immersed in warmed enzyme solution, and the detach button was pressed.The audible beep did not sound and the embolic coil did not detach.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.Two enpower control cables were returned without any additional packaging.The devices are not marked with lot numbers visible from the outside of the device, so they will be designated device a and device b.Both devices were returned with no visible external damage.Device a: the device was connected to detachment control box (dcb) and to 50 resistor assembly, and the dcb power was turned on.The system ready light illuminated.The remote detach button was pressed.The detach light illuminated and the audible detachment beep sounded.The device was connected to multimeter 70042-04d and ccb female jumper 80129-01b and the resistance was measured.The resistance was 1.0 , which is within the specification range of =2.0.Device b: the device was connected to detachment control box (dcb) and 50 resistor assembly, and the dcb power was turned on.The system ready light illuminated.The remote detach button was pressed.The detach light illuminated and the audible detachment beep sounded.The device was connected to multimeter 70042-04d and ccb female jumper 80129-01b and the resistance was measured.The resistance was 0.9, which is within the specification range of =2.0.A review of manufacturing documentation associated with these lots presented no issues during the manufacturing or inspection processes related to the reported complaint.The micrusframe 10 complaint of failure to detach was confirmed.For enpower cables, the complaint that the devices did not function was not confirmed since both devices passed functional testing.The embolic coil could not be detached under laboratory conditions, and the resistance of the device was out of specification.The severe kink identified in the dpu core wire is sufficient to damage the electrical connection between the hub and the rh coil of the device, which would prevent the rh coil from receiving heat when the detach button is pressed.The dcb system ready light is intended to ensure that a proper electrical connection is present prior to detaching the embolic coil, and if the system ready light is not illuminated the detach cycle will not initiate correctly.According to the instructions for use (ifu) for the dcb2, if the system ready light does not illuminate, it can indicate a fault in the microcoil system.While the exact sequence of events is unknown, the kink in the dpu core wire is likely to be the cause of the failure to detach.Final assembly devices are inspected for core wire defects such as kinks at 100%, so it is very unlikely that a kink as severe as the one observed on this device was present when the device left the manufacturing facility.Without return of packaging and shipping materials, it cannot be determined whether the damage occurred in transit, during storage, or when the device was being prepared and used.There is no current safety signal identified related to the reported event based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

Manufacturer Narrative

The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

• Brand Name: MICRUSFRAME COIL
• Type of Device: 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: 6837662
• MDR Text Key: 85296754
• Report Number: 2954740-2017-00246
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077831
• UDI-Public: (01)10886704077831(17)191231(10)S13059
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: MFR100517
• Device Lot Number: S13059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 09/25/2017; 10/31/2017
• Supplement Dates FDA Received: 10/19/2017; 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR