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

Catalog Number	CDX18041530
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2016-00270.Additional procode: krd.(b)(4).Concomitant products: sheath introducer (medikit); guidewire (radifocus gt gw, terumo); guiding catheter (ja-1); micro catheter (light house); yconnector (terumo); enpower.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.Since there was no evidence of a manufacturing issue related to the event, no corrective action will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during coil embolization, it was reported that a deltamaxx coil (cdx18041530/c41628) failed to detach.The procedure was partial splenic artery embolization at the peripheral lienal artery.The patient was a (b)(6) whose vessels were mildly torturous and not calcified.The guiding catheter and the micro catheter were accessed to the lesion form the right femoral artery.The deltamaxx (complaint product) was inserted as 1st coil, and the physician tried to detach the coil.However it was found that the green system ready light of the enpower box did not illuminate.The box was rebooted and connector was reconnected to the cable but the light did not illuminate.Therefore the coil was replaced with another one.After which 3 coils (idc 4 mm / deltamaxx 3mm /cashmere 3mm) and also micrus products were used in order without any issues.The procedure was successfully completed without further issues or delay.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 or damage was noted on the products prior to and after the event.No unintended detachment was observed in the vessel or in the microcatheter.The product has already been disposed and not available for the 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: 6089287
• Report Number: 2954740-2016-00270
• Device Sequence Number: 1360082
• Product Code: HCG
• UDI-Device Identifier: 10878528008559
• UDI-Public: (01)10878528008559(17)210228(10)C41628
• 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): 10/31/2016

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: 02/28/2021
• Device Catalogue Number: CDX18041530
• Device Lot Number: C41628
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2016
• Initial Report FDA Received Date: 11/09/2016
• Patient Sequence Number: 1
• Patient Age: 88 YR