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

Catalog Number	CPL10020430
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, a deltaplush coil (cpl10020430/c38767) could not be detached during the procedure.They used another one to complete the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, a deltaplush coil (cpl10020430/c38767) could not be detached during the procedure.They used another one to complete the procedure.There was no report of patient injury.Multiple attempts to obtain additional information were unsuccessful.The device was returned with its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.The device positioning unit (dpu) core wire has protruded from the skive of the translucent introducer sheath, and the returned device is tangled.The device was gently untangled.The distal end of the embolic coil is located in the green introducer, near its proximal end.The protrusion of the dpu includes the tip coil and extended coil.There is a kink in the dpu core wire approximately 77 cm from the proximal end.The ball tip is intact.The embolic coil is slightly stretched.The distal end of the skive of the translucent introducer sheath is spread open and the edges are damaged.The articulating joint appears to be compressed longitudinally.The condition of the resistance heating (rh) coil is obscured by the translucent introducer sheath.The extended coil section of the dpu protrudes from the skive of the translucent introducer sheath.The v-notch of the resheathing tool is undamaged.The resistance of the device was tested, and the resistance was 50.8, which is within the specification range of 48.5 ¿ 56.The device was connected to a lab sample detachment control box dcb000005-00 (dcb) with a standard connecting cable and the power was turned on.The system ready light illuminated.An attempt was made to advance the embolic coil out of the green introducer to test detachment.The embolic coil could not be advanced because of the protrusion of the extended coil through the skive of the translucent introducer sheath.Since the embolic coil cannot be advanced out of the green introducer, detachment cannot be tested.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the embolic coil fails to detach cannot be confirmed.Since the embolic coil cannot be advanced out of the introducer due to protrusion of the extended coil through the skive of the translucent introducer sheath, detachment cannot be tested.The device meets release criteria for resistance, and the dcb system ready light illuminates when the device is attached.The protrusion of the dpu core wire at the tip coil suggests that the resheathing tool was advanced over this section of the dpu while unsheathing the device.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more delicate and flexible sections of the dpu (the tip coil and extended coil) inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing these sections into the microcatheter, there is a risk that these sections will be unsheathed and pass through the resheathing tool, which can cause them to protrude from the introducer.In addition, the bend in the dpu core wire, stretched embolic coil, and compressed articulating joint all suggest that excessive force was applied to the device, possibly in an attempt to overcome resistance.Damage to the skive of the translucent introducer sheath near the green introducer may be due to overcompression of the rotating hemostatic valve (rhv).The ifu cautions against fastening the rhv too tightly around the introducer sheath, since excessive pressure may cause damage to the introducer sheath and/or the microcoil, and may present resistance to advancement.There is no current safety signal identified related to the reported events based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6906965
• Report Number: 2954740-2017-00278
• Device Sequence Number: 1141623
• Product Code: HCG
• UDI-Device Identifier: 00878528008224
• UDI-Public: (01)00878528008224(17)200131(10)C38767
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/08/2017

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: 01/31/2020
• Device Catalogue Number: CPL10020430
• Device Lot Number: C38767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 10/02/2017
• Supplement Report FDA Received Date: 11/29/2017
• Patient Sequence Number: 1