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

Catalog Number	CDX18031230
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continued from section d2b: krd/hcg.Concomitant products: sheath introducer (4.5fr gs), guidewire (meister, medikit), guiding catheter (4.5fr gs), micro catheter (exelesio1018), y connector (terumo), enpower.It was reported that the device would be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during coil embolization for a type ii endoleak at the inferior mesenteric artery, a deltamaxx coil (cdx18031230/s11837) failed to detach.Initially a presidio coil was placed.As the second coil, the complaint deltamaxx was taken out from its package.Pre-deployment electrical check was performed, and the coil was inserted, but the coil could not be detached when the detachment button was pressed.The physician pressed the button again, but it was found that the light had gone off, so the delivery wire was withdrawn and the coil was removed.The coil was replaced with another deltamaxx, and the procedure was successfully completed by placing 10 coils without further issues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 or after the event.No unintended detachment was observed in the vessel or in the microcatheter.It was reported that the product would be returned for investigation.No further information was available.
Additional Manufacturer Narrative
Conclusion: the device was returned for analysis.The detachment fiber did not receive heat and melt.The device positioning unit (dpu) passed electrical testing with resistance at 51.1 ohms (range 48.5/56.0 and the lab sample enpower and cable systems ready green light illuminated.The coil detached on the first detachment cycle.The post-detachment resistance passes at 51.2 ohms.Post-detachment shows that the detachment fiber received heat and melted.No manufacturing defects were found.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 complaint of the coil¿s non-detachment was not confirmed.The dpu passed electrical testing and the coil detached on the first detachment cycle; therefore, the root cause of the coils non-detachment cannot be determined.In addition, without the return of the complete detachment system used in the procedure, it cannot be determined if these components contributed to the complaint event.Since there was no evidence of a manufacturing issue related to the event, 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: 6557031
• Report Number: 2954740-2017-00100
• Device Sequence Number: 16402150
• Product Code: HCG
• UDI-Device Identifier: 10878528008542
• UDI-Public: (01)10878528008542(17)210930(10)S11837
• 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): 04/18/2017

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: 09/30/2021
• Device Catalogue Number: CDX18031230
• Device Lot Number: S11837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2017
• Supplement Report FDA Received Date: 05/18/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE SECTION H10
• Patient Age: 55 YR