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

Catalog Number	CPL10020630
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The product is expected to be returned for analysis, however it has not been received.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a deltaplush coil (cpl10020630/c26421) could not be detached during a procedure.Another one was used to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #3013875781-2017-00006.Conclusion: based on the information, the event could not be confirmed.The product was not returned for analysis; however 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.There were no significant safety signals identified related to the reported event based on a review of complaint history for the device.Therefore, no corrective actions will be taken at this time.
Additional Manufacturer Narrative
This follow-up mdr is the only report being submitted for mfr report #3013875781-2017-00006.(b)(6).
Additional Manufacturer Narrative
This follow-up mdr will be the only report submitted for mfr report #3013875781-2017-00006.This mdr is being submitted to report the following additional information received on january 03, 2018: there was no damage noted to the coil, coil delivery system, or coil detachment system prior to the procedure.An enpower dcb and connecting cable were used during the procedure, both lot numbers are unknown.A pre-deployment electrical check was performed and a low battery light was not observed during the case.The green system ready light illuminated.All connections appear to fit properly without the application of excessive force.The same enpower dcb and connecting cable were used successfully with subsequent coils.The event did not result in a procedural delay.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• MDR Report Key: 6954355
• Report Number: 3013875781-2017-00006
• Device Sequence Number: 13818158
• Product Code: HCG
• UDI-Device Identifier: 00878528008231
• UDI-Public: (01)00878528008231(17)190430(10)C26421
• 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,Followup,Followup
• Report Date (Section B): 09/20/2017

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: 04/30/2019
• Device Catalogue Number: CPL10020630
• Device Lot Number: C26421
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 12/07/2017; 01/03/2018; 01/10/2018
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 01/02/2018; 01/07/2018; 01/10/2018
• Patient Sequence Number: 1