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

Catalog Number	CDX18144530
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is initial/final mdr report submitted for this complaint.Additional procode krd.(b)(4).Sheath introducer (terumo), guidewire (asahi intecc), guiding catheter (4fr diacrisis) , micro catheter (progreat cube, terumo) , balloon catheter (piolax) and enpower (b)(6).(b)(4).Based on the information, the reported event could not be confirmed.The product was not returned for analysis; however 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.There is no current safety signal identified related to the reported event(s) based on review(s) of complaint history(ies) for the device.
Event or Problem Description
As reported by a healthcare professional, during the procedure coil introducer damage was reported when using two deltamaxx coils (cdx18246030/c38840 and cdx18144530/c34584) and another deltamaxx coil (cdx18144530/c36948) unraveled and prematurely detached.The procedure was coil embolization of an aneurysm at the splenic artery.The patient was a female whose vessel was moderately torturous and not calcified.The deltamaxx coil (cdx18246030/c38840) was used as the framing coil however "the balloon could not be handled", so the physician tried to re-sheath the coil but introducer sheath broke and the coil could not be re-sheathed.Another deltamaxx coil (cdx18144530/c34584) was used as a filling coil, but the micro catheter slid back proximally and the coil would not fit into the catheter, so the physician tried to re-sheath the coil however the introducer sheath got broken and the coil could not be re-sheathed.Excessive force was not used when handling the catheter and the coil.After this issue, the microcatheter was reinserted.A deltamaxx coil (cdx18144530/c36948) was inserted however due to incorrect positioning of the catheter tip in the aneurysm the coil did not fit in the aneurysm.When the physician was placing the coil in and out of the aneurysm, the coil unraveled when being reinserted.The coil then prematurely detached in the aneurysm, after which the coil was retrieved using both a snare and ensnare.The coil retrieval caused a procedural delay of 180 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 ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The products are 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: 6710457
• Report Number: 2954740-2017-00201
• Device Sequence Number: 13886542
• Product Code: HCG
• UDI-Device Identifier: 10878528008658
• UDI-Public: (01)10878528008658(17)200731(10)C36948
• 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): 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: CDX18144530
• Device Lot Number: C36948
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2017
• Initial Report FDA Received Date: 07/13/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention