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

Catalog Number	CDX18052030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is initial/final mdr report being submitted with associate mfr# 2954740-2017-00069.(b)(4).Concomitant medical products: sheath introducer (terumo); guidewire (ashahi); micro catheter (logos); yconnector (terumo); ecb.The deltamaxx coil will not be returned, therefore the root cause of the coils resistance, becoming stuck, and its unraveling 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 action will be taken at this time.
Event or Problem Description
As reported by a healthcare professional, during the procedure, unraveling and resistance was experienced when using a deltamaxx18 sys 5x20 coil.The procedure was coil embolization for balloon-occluded retrograde transvenous obliteration at the gastric vein.The deltamaxx coil (complaint product) was used after several coils were used but it got stuck in the micro catheter, furthermore, the coil was unraveled.The coil was removed.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 a constant flush was maintained at all times.No visible defect/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 is 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: 6457011
• Report Number: 2954740-2017-00069
• Device Sequence Number: 875318
• Product Code: HCG
• UDI-Device Identifier: 10878528008566
• UDI-Public: (01)10878528008566(17)210331(10)S10393
• 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): 03/14/2017

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: 03/31/2021
• Device Catalogue Number: CDX18052030
• Device Lot Number: S10393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Initial Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1