MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC418155030
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been forwarded to codman for evaluation however evaluation is not yet complete.When evaluation is complete the results will be provided within 30 days.Dhr: 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.(b)(4).
Event or Problem Description
The contact from the facility reported that during coil embolization of an aneurysm (15mm in size) at hepatic artery two presidio coils (pc4181550-30/c35982, pc4181447-30/c34163) an orbit galaxy coil (640cf0721/17383916) were stuck in the microcatheter.The enpower control cable was not clean upon opening however did not provide any reason.The location that the device was not clean is unknown however the issue was not discovered during opening.The patient was a male of unknown age; the level of tortuousity was heavy, and no calcification of the vessels.A sheath introducer (terumo), a guidewire (asahi), a progreat microcatheter (terumo), a lighthouse (piolax), and a y connector (terumo) were used for this procedure.The complaint presidio coils were the first two coils used in the procedure.The first coil was stuck at the distal area in the microcatheter (mc), and it was retrieved.The resistance was strong while retrieving as well.The second coil was stuck in the middle of mc during mc placement.It didn't move at all and retrieved when the mc was retrieved.Then mc was replaced and the procedure continued.The complaint galaxy was used after the physician inserted more than 10 coils.It was stuck in the middle of the mc, and it was retrieved.Peeling was done successfully and the coil was decontaminated after retrieved.When the physician cleaned the inside the mc and tried to reuse, it was stuck in the introducer sheath and couldn't even deliver.The complaint enpower control cable was not clean when it was opened by mistake.Gc and mc were quite unstable and took about 6 hours for the procedure.The procedure was successfully completed with a 30-minute delay.There was also no patient injury/complications 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 times.No visible defect/damage was noted on the products prior to (and after) the event.It is unknown if there were any kinks or bends on the coils or microcatheter used in the event.No unintended detachment was observed in the vessel or in the microcatheter.The product will be returned for the investigation.No further information is available.
Additional Manufacturer Narrative
Very limited information was received.The unspecified progreat microcatheter was not returned (comes in two inner lumens of 0.022¿ and 0.025¿.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned 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.Two devices were received unidentified in the same bag with no prior notice received.This device cannot be definitively identified due to the coil being completely stretched.However it is not the other presidio in the complaint because the size of the other coil matches the size of the presidio lot c34163.The coil¿s stretching damage is unreported.The coil was returned detached.The detached coil was returned severely stretched and damaged.The coils unreported detachment was mechanical in nature.The fracture of the coil¿s socket ring was ductile in nature requiring external force.No material defects were found.Located on the top proximal end of the resheathing tool in the open cutout section, the v notch has been severely fractured with the damaged edges elevated above the surface plane.A section of the sheath is seen protruding through the facture.The locking mechanism has compression and stretching damage.Due to the severe damage to the coil no duplication of the field complaint was possible.No manufacturing defects were found.Due to improper handling, cleaning, packaging, lack of identification on two entangled devices, the circumstances of how and when all the above unreported damage occurred cannot be determined as it was stated in the complaint that, ¿¿no visible defect/damage was noted on the products prior to (and after) the event¿¿ conclusion: the complaint of the coil becoming stuck inside the microcatheter is not confirmed.Due to the fact that the device was returned unidentified, entangled with another device, stretched, detached, all multiple unreported severe damage, the root cause of the coil becoming stuck cannot be determined, however the evidence as received exhibits two possible contributing factors to the coil becoming stuck.These contributing factors may have worked in tandem or separately causing a cascading effect to the complaint event.The evidence highly suggests that the primary contributing factor to the coil becoming stuck inside the microcatheter may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the v notch of the resheathing tool and became embedded.In addition, the locking mechanism may not have been fully disengaged off the core wire.The sheath also caught the v notches extended edges.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which may have preventing the coil from advancing.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿hold the introducer sheath (loosely-looped) in the left hand.Keeping the introducer tip near the re-sheathing tool, grasp the distal end of the re-sheathing tool between your left thumb and forefinger.Grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end, and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger, as shown in figure 3¿¿ caution: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1in.(2-3cm).¿ in addition, without the return of the progreat microcatheter used the procedure, it cannot be determined if this component had any additional contributions to the complaint event.The secondary contributing factor and the common denominator in both complaints was the selection of an over-sized microcatheter that was used with an 18 series microcoil system.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿proper selection of the appropriately sized microcatheter is required to avoid damage to the codman microcoil system and to minimize potential complications.Microcatheter selection is also determined by the physician and is predicated by the location of the aneurysm, patient safety, and physician preference.The codman microcoil 18 system is compatible with microcatheters with inner lumen diameters ranging from 0.017 to 0.021 in (0.356 to 0.533 mm).The progreat microcatheter comes in two inner lumens of 0.022¿ and 0.025¿ both of which are outside the recommendation of the ifu.In addition, without the return of the progreat microcatheter used in the procedure, it cannot be determined if this component had any additional contributions to the complaint event.Dhr: 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.Device handling is the likely cause of the unreported damage although the exact circumstance cannot be determined since the review of the manufacturing documentation did not find any issue that led to the unreported damages.Additionally, the complaint of the coil becoming stuck inside the microcatheter was not confirmed although use factors as described in the ifu may have contributed.Therefore no additional corrective action will be taken at this time.

• Brand Name: PRESIDIO 18 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 5951542
• Report Number: 2954740-2016-00207
• Device Sequence Number: 1131999
• Product Code: HCG
• UDI-Device Identifier: 00878528003274
• UDI-Public: (01)00878528003274(17)200331(10)C35982
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K002056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2016

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: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: PC418155030
• Device Lot Number: C35982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/19/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 10/07/2016
• Patient Sequence Number: 1