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

Catalog Number	CDX18246030
Medical Device Problem Codes	Difficult To Position (1467); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Procode: krd/hcg.Concomitant product(s): guidewire (radifocus, terumo), microcatheter (prowler select plus), y connector (okay, terumo), enpower cable.Conclusion: the device was not returned for analysis.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 positioning difficulty and coil unraveling could not be confirmed without product return for analysis.The root cause of the event could not be determined based on the information provided; however, the coil may have become attached to the aneurysm or itself during the repositioning resulting in the coil unraveling.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a left internal iliac artery aneurysm, a deltamaxx (cdx18246030/(b)(4)) was difficult to place and unraveled.The deltamaxx was the first coil used, but the coil was difficult to place, was moved in and out of the aneurysm several times, and unraveled.The coil was removed from the patient¿s body with the prowler select plus microcatheter, and the coil was replaced with another one (presidio).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.The product was not available for investigation.No further information is available.

• 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: 6557009
• Report Number: 2954740-2017-00099
• Device Sequence Number: 802369
• Product Code: HCG
• UDI-Device Identifier: 10878528008757
• UDI-Public: (01)10878528008757(17)200930(10)C37921
• 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
• Report Date (Section B): 04/19/2017

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: 09/30/2020
• Device Catalogue Number: CDX18246030
• Device Lot Number: 1754
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/10/2017
• Patient Sequence Number: 1
• Patient Age: 65 YR