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

Catalog Number	CDX18083530
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the only initial mdr that will be submitted for mfr report#2954740-2017-00179.(b)(4).The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
It was reported by a healthcare professional that a deltamaxx coil (cdx180835-30/c39755), a prowler select plus microcatheter (606-s255fx/17647636) and an enpower control cable(ecb000182-00/s11830) were used during a coil embolization procedure of a ruptured thoracic aneurysm at the left subclavian artery where the coil could not be detached and was found to have unraveled and entangled with the tip of the microcatheter.After anchoring with a presidio coil, the deltamaxx coil (complaint product 1), used as the 3rd coil, could not be detached.An attempt was made to remove the coil but it was unraveled.All systems were removed from the patient as the coil was entangled in the tip of the prowler select plus microcatheter (complaint product 2); the coil was removed completely.There was concern that the microcatheter was broken so the enpower control cable (complaint product 3) was also replaced.It is possible that the cable got dirty during that time.The coil was replaced with another of the same size and the procedure was successfully completed by 4 coils without further issues or delay.Reportedly, the patient was a (b)(6) male, whose vessel was heavily tortuous and heavily calcified.A y connector (okay, goodman) was also used for this procedure.There was also no patient injury/complication reported and no delay in procedure.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.The product are not available for the investigation.No further information is available.
Additional Manufacturer Narrative
This final mdr will be the only report submitted for mfr report #2954740-2017-00179.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.Therefore, no corrective actions will be taken at this time.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6658448
• Report Number: 2954740-2017-00179
• Device Sequence Number: 1530910
• Product Code: KRD
• UDI-Device Identifier: 10878528008597
• UDI-Public: (01)10878528008597(17)191231(10)C39755
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K120274
• 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): 05/29/2017

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: 12/31/2019
• Device Catalogue Number: CDX18083530
• Device Lot Number: C39755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2017
• Supplement Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 09/22/2017
• Patient Sequence Number: 1
• Patient Age: 75 YR