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

Catalog Number	CPL10030630
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product(s): a sheath introducer (5fr long sheath), a guidewire (joker, (b)(4) lifeline), a guiding catheter (5fr imager, boston scientific) and a micro catheter (corsair pv, (b)(4)) 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, during coil embolization of an ima artery, a deltaplush coil (cpl10030630/ c26878) failed to detach.Initially a 3mm x 6cm deltaplush coil was detached without any problem.The physician tied to detach the complaint deltaplush as the second coil, but detachment error occurred for 4 times.The coil was replaced with another one (presidio10) to complete embolization.A corsair pv microcatheter was used for the procedure.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication 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 time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.No further information was available.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during coil embolization of an ima artery, a deltaplush coil (cpl10030630/ c26878) failed to detach.Initially a 3mm x 6cm deltaplush coil was detached without any problem.The physician tied to detach the complaint deltaplush as the second coil, but detachment error occurred for 4 times.The coil was replaced with another one (presidio10) to complete embolization.A corsair pv microcatheter was used for the procedure.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication 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 time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.No further information was available.The device positioning unit (dpu) was returned fully unsheathed and with no embolic coil attached.There was a kink in the dpu core wire at the end of the strain relief, and another approximately 50 cm distal to the end of the strain relief.The rh coil did not receive heat and melt.There appears to be mechanical damage to the distal end of the dpu.Since the embolic coil was not attached, detachment of the coil could not be tested.The resistance of the dpu was tested with multimeter id#70042-04d (photo 7) and was 50.2 ¿, which is within the specification range of 48.5 ¿ 56.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 could not be detached could not be confirmed because the embolic coil was not returned.The detachment occurred post-procedure since it was reported that the coil did not detach during the procedure.The coil did not receive heat and melt, suggesting that the detachment cycle was not fully initiated during the procedure.Without the return of the dcb and ecb, it cannot be determined whether either of these devices contributed to the reported complaint.There is no current safety signal identified related to the reported event based on review(s) 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: 6711795
• Report Number: 2954740-2017-00202
• Device Sequence Number: 1566232
• Product Code: HCG
• UDI-Device Identifier: 00878528008286
• UDI-Public: (01)00878528008286(17)190429(10)C26878
• 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): 06/22/2017

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: 04/29/2019
• Device Catalogue Number: CPL10030630
• Device Lot Number: C26878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2017
• Initial Date Received by Manufacturer: 06/22/2017
• Supplement Date Received by Manufacturer: 09/21/2017
• Initial Report FDA Received Date: 07/13/2017
• Supplement Report FDA Received Date: 09/21/2017
• Patient Sequence Number: 1