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	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode krd.(b)(4).Concomitant products: micro catheter (coiling support, hi-lex corporation); enpower cable (ecb00018200/p11482).The deltamaxx will not be returned, therefore, the root cause of the coils non-detachment cannot be determined.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.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of an aneurysm at the splenic artery a deltamaxx coil failed to detach.The patient¿s vessels were not torturous and not calcified.The physician pressed the detachment button of the enpower cable but the coil could not be detached.It was confirmed the power light illuminated and during the detachment cycle the detachment light illuminated.The coil was replaced with a competitive coil, it is unknown if the enpower cable was exchanged.There were no damages noted on the coil prior to use or upon removal.The procedure was successfully completed without further issues.However, due to the event the procedure was delayed by 10 minutes.There were no patient injuries or complications reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.No visible defect/damage was noted on the products prior to (and after) the event.The product has already been disposed and is not available for investigation as there was blood on the products.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: 6314281
• Report Number: 2954740-2017-00026
• Device Sequence Number: 19062303
• Product Code: HCG
• UDI-Device Identifier: 10878528008597
• UDI-Public: (01)10878528008597(17)201130(10)C39458
• 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): 02/03/2017

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: 11/30/2020
• Device Catalogue Number: CDX18083530
• Device Lot Number: C39458
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/09/2017
• Patient Sequence Number: 1
• Patient Age: 63 YR