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

Catalog Number	CDX18165030
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/17/2017
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# 2954740-2017-00068.Additional procode: krd.(b)(4).Concomitant medical products: micro catheter (45 °prowler select plus/ str); y connector (okay, goodman); enpower cable.The deltamaxx will not be returned, therefore the root cause of the coil damage cannot be determined.A review of the manufacturing documentation associated with this lot (c37790) 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 a deltamaxx coil got damaged in an attempt to re-sheath the coil.The procedure was pre-tevar coil embolization for dissociation cavity near the upper part of the renal artery.The patient¿s vessel was heavily torturous and heavily calcified.Five (5) coils (presidio) were used with double catheter and the deltamaxx (complaint product) was used after anchor.However, the deltamaxx coil was too long for the lesion and also the micro catheter came off, so it was attempted to retrieve the coil to correct the position of the catheter.The coil got damaged when re-sheathing was attempted, it is unknown which part of the coil was damaged.The coil was replaced with another deltamaxx coil (lot unknown).The micro catheter was reinserted.And the procedure was completed without further issues or delay.There were no damages reported on the complaint coil prior to use.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 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: 6456751
• Report Number: 2954740-2017-00068
• Device Sequence Number: 563374
• Product Code: HCG
• UDI-Device Identifier: 10878528008672
• UDI-Public: (01)10878528008672(17)200831(10)C37790
• 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): 03/17/2017

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: 08/31/2020
• Device Catalogue Number: CDX18165030
• Device Lot Number: C37790
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2017
• Initial Report FDA Received Date: 04/04/2017
• Patient Sequence Number: 1