MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPLUSH - PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	DPL10040820
Medical Device Problem Codes	Physical Resistance (2578); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product code: krd/hcg.It is anticipated that the device will be returned for analysis; however, the device has not been returned.Three attempts to obtain additional information have been unsuccessful.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, the deltaplush coil (dpl10040820/ c16998) could not advance through the unspecified microcatheter.When they pulled it back, it deformed.There were no potential adverse events associated with the event.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, the deltaplush coil (dpl10040820/ c16998) could not advance through the unspecified microcatheter.When they pulled it back, it deformed.There were no potential adverse events associated with the event.Multiple attempts to obtain additional information were unsuccessful.The device was returned for analysis.Unreported damage of the device positioning unit (dpu) kinking located 75.5 centimeters off the proximal end was found.Unreported damage of the dpu protruding 85.5 centimeters off the distal tip of the green introducer was found.There is no sheath damage at the protrusion site.The coils socket ring was pushed down inside the outer sheath.The articulating junction is now in a fixed position with the distal tip of the dpu and the proximal end of the coil no longer concentric to each other.There is intermittent compression and buckling damage to the coils length.The v notch of the resheathing tool has been fractured.The locking mechanism has compression and stretching damage.No manufacturing defects were found.The circumstances of how and when all the unreported damage occurred cannot be determined.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 the complaint of the coil unable to be advanced through the unidentified microcatheter was not confirmed.The complaint of the coil damage was confirmed.While the exact root cause of the coils advancement difficulty and its coil damage cannot be determined, the evidence as received highly suggests that the most likely contributing factor 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 been the dpu, caused the dpu to protrude outside the sheath, and caused the compression and buckling damage found to the coil.In this condition the coil cannot be advanced.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.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 1 in.(2-3 cm).¿ 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 contributed to the complaint event.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.

• Brand Name: DELTAPLUSH - PLATINUM MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6475442
• Report Number: 2954740-2017-00070
• Device Sequence Number: 13545847
• Product Code: HCG
• UDI-Device Identifier: 00878528008156
• UDI-Public: (01)00878528008156(17)180323(10)C16998
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K083646
• 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): 03/17/2017

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: 03/23/2018
• Device Catalogue Number: DPL10040820
• Device Lot Number: C16998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 04/27/2017
• Patient Sequence Number: 1