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	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant products: sheath introducer (terumo), guiding catheter (4fr contrast catheter), enpower detachment control box 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 for placing a reservoir, a deltamaxx coil (cdx180312-30, s11663) failed to detach.The green system ready light did not illuminate.It did not power-on and the coil could not be detached.Therefore, the coil was replaced with another one (same size).The procedure was successfully completed without further issues.However, due to the event it was delayed for 10 minutes.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 instructions for use (ifu), and a 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.No further information was available.
Additional Manufacturer Narrative
Conclusion: as reported by a healthcare professional, during coil embolization for placing a reservoir, a deltamaxx coil (cdx180312-30/ s11663) failed to detach.The green system ready light did not illuminate.It did not power-on and the coil could not be detached.Therefore, the coil was replaced with another one (same size).The procedure was successfully completed without further issues.However, due to the event it was delayed for 10 minutes.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 instructions for use (ifu), and a 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.No further information was available.The device was returned for analysis.The device positioning unit (dpu) failed electrical testing with resistance at 48.1 ohms (range.48.5/56.0) and the lab sample enpower detachment control box and cable systems ready green light did not illuminate.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 coils non-detachment was confirmed.The dpu failed electrical testing.While the root cause cannot be determined, the most likely contributing factor to the coils non-detachment may have been due to wire damage and/or to a solder joint connection fracture in the resistive heating coil.The circumstances of how and when this damage occurred cannot be determined as all microcoil systems are tested prior to final packaging.In addition, without the return of the complete detachment system used in the procedure, it cannot be determined if these components had any additional contributions 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: 6504288
• Report Number: 2954740-2017-00085
• Device Sequence Number: 18835100
• Product Code: HCG
• UDI-Device Identifier: 10878528008542
• UDI-Public: (01)10878528008542(17)210731(10)S11663
• 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): 03/29/2017

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: 07/31/2021
• Device Catalogue Number: CDX18031230
• Device Lot Number: S11663
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2017
• Supplement Report FDA Received Date: 04/25/2017
• Patient Sequence Number: 1
• Patient Age: 83 YR