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

Catalog Number	GLX120406
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00093.Additional procode: krd.(b)(4).Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned by the end user/hospital before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.As viewed by the unaided through the return packaging, an unreported coil detachment was found.The dpu was returned outside the introducer sheath.The proximal end of the undamaged detached coil was located 12.0 centimeters off the distal tip of the green introducer adjacent to the clear/green junction.The coil was mechanically detached.Located at the distal tip of the skive adjacent to the clear/green introducer junction is severe mechanical sheath damage that caused the skive to open up.This damage was caused by the resheathing tool.No manufacturing defects were found.The exact circumstances of how and when the coil was mechanically detached cannot be determined.The complaint of the resheathing difficulty is confirmed.While the exact root cause cannot be determined, the evidence as received highly suggests that the most likely contributing factor to the resheathing difficulty may have occurred when the resheathing tool was advanced past the introducer¿s clear/green junction and onto the proximal end of the green introducer sheath.When the resheathing tool was retracted across the clear/green junction, the resheathing tool most likely damaged the sheath causing the skive to open up which allowed the dpu to protrude through the sheath.This is most likely when the coil was mechanically detached from the dpu remaining inside the introducer sheath.In this condition the unit cannot be resheathed.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿¿continue sliding the introducer tip until just before the tip reaches the distal end of the re sheathing tool, leaving approximately 1 inch of the unsheathed introducer sheath still visible¿¿.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.Based on the information and the analysis, the event was confirmed, procedural factors likely contributed to the event.Without return of concomitant products it cannot be determined if those components had any additional contributions to the complaint event.Additionally, review of this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Therefore, no corrective actions will be taken at this time.
Event or Problem Description
As reported by a health care professional, during the procedure resistance was experienced with two micrus frames 10 3.5 x 6.6 coils (mfr100356/ c40274r) and two galaxy g3 xsft 4 mm x 6 cm coils (glx120406/lot# s11626 and s11362) failed to re-sheath.The procedure was coil embolization of the communicating segment of the left internal carotid artery.The aneurysm measured 4.75 x 3.75.After the competitor¿s microcatheter was placed, the coil was prepared (micrus frame s 10 3.5 x 6.6 lot #c40274r) and after sufficient flushing (droplets appearing at the green/clear transition on the delivery tube) the doctor advanced the coil only to have it get stuck in the catheter just after passing the hub.After 3 attempts to re-flush and insert, we finally tried another micrus frame s 10 3.5 x 6.6 (lot number c40274r) and the same thing happened.The physician switched to g3 xtra soft 12- 4 x 6.After flushing and advancing to the tip of the microcatheter, the echelon catheter kicked out of the aneurysm with the balloon inflated.The doctor removed the coil which was reported to be necessary to reposition the echelon back into the aneurysm via a guidewire, however the coil could not be re-sheathed so it could not be used after the catheter was back in position.We took another g3 xsoft 12 4 x 6 and the exact same scenario happened (catheter kicked out, then the coil would not re-sheath).Finally, the physician chose a g3 xtrasoft 3.5 x 5, 2 x 2 and another 2 x 2 (all successfully placed) before switching over to a couple of nano coils.The same echelon catheter was used during the entire case and there were no issues with it.An adequate flush was maintained through the catheter.The patient is doing fine.The procedure was delayed by 15 minutes due to numerous attempts to insert the micrus frame coils and resheath the g3 coils.There were no damages noted on the complaint products or the concomitant devices prior to use or upon removal.It was reported that the four complaint coils are available for return.

• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6551382
• Report Number: 2954740-2017-00093
• Device Sequence Number: 18888530
• Product Code: HCG
• UDI-Device Identifier: 10886704077725
• UDI-Public: (01)10886704077725(17)190630(10)S11362
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: GLX120406
• Device Lot Number: S11362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 05/08/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON 10 MICROCATHETER HYPERGLIDE BALLOON