MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	PC410041230
Medical Device Problem Codes	Kinked (1339); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary: very limited information was received.The unidentified microcatheter and the rotating hemostatic valve (rhv) were not returned.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.The locking mechanism has compression and stretching damage.The resheathing tool¿s v notch has been fractured.Located at the distal tip of the resheathing tool, the device positioning unit (dpu) is protruding outside the sheath.Located and starting 1.0 centimeters off the distal tip of the dpu, the grey tip coil section has intermittent sections of buckling.The coil¿s socket ring has been pushed down inside the outer sheath.The proximal end of the coil has compression and buckling damage which also caused a loss of the secondary winding.The remainder of the coil is undamaged.No manufacturing defects were found.Conclusion: the complaint of the coil unable to be inserted into the unidentified microcather cannot be confirmed.Without the return of the unidentified microcatheter and the rhv used in the procedure, the root cause of the introduction difficulty cannot be determined, however the evidence as received highly suggests that the most likely contributing factor to the coils insertion difficulty into the unknown microcatheter may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the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.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 caused the dpu to protrude outside the sheath, buckled the grey tip coil section in multiple sections, may have pushed the coil¿s socket down inside the outer sheath, and caused buckling and compression damage to the proximal section of the coil which also caused a loss of secondary shaping.In this condition the coil cannot be introduced into the microcatheter.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¿¿ 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 identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components 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.Based on the information and the damages to the device it is plausible that the reported failures occurred during the procedure, however procedural factors outlined in the ifu 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
The contact from the facility reported that during a coil embolization procedure the presidio coil (b)(4) could not be inserted into microcatheter.A new coil was used to complete the procedure.There was no report of patient injury.There was no significant clinical delay to the procedure as a result of the issue.The device did not kink or bend at any time prior to the resistance/friction.The concomitant devices did not kink or bend at any time.There were no damages on any part of the device when the device was removed from the patient.An adequate continuous flush was maintained through the catheter.During returned device investigation the embolic coil was found buckled and compressed.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6259080
• Report Number: 2954740-2017-00010
• Device Sequence Number: 665217
• Product Code: HCG
• UDI-Device Identifier: 00878528003007
• UDI-Public: (01)00878528003007(17)191031(10)C30506
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 12/20/2016

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: 10/31/2019
• Device Catalogue Number: PC410041230
• Device Lot Number: C30506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2017
• Initial Report FDA Received Date: 01/17/2017
• Patient Sequence Number: 1