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

Catalog Number	CDX18185530
Medical Device Problem Codes	Premature Activation (1484); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is one of one initial/final mdr report being submitted for this complaint.Additional procode: krd.(b)(4).The deltamaxx will not be returned, therefore the root cause of the coil resistance, its premature detachment, and its stretching 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 health care professional, during the procedure the physician experienced resistance when using deltamaxx coil (cdx18185530/c33289) and prowler select plus catheter (606s255fx/17450085).The procedure was coil embolization of an aneurysm on both sides of the internal iliac artery before evar.Patient was an (b)(6) old male whose vessels were heavily torturous and heavily calcified.The complaint deltamaxx coil was the 9th coil being used in the procedure; there was strong resistance felt between the coil and the micro catheter.Therefore the physician tried to retrieve the coil slowly, but it unraveled.Furthermore, the coil remained in the micro catheter.The coil was removed with the micro catheter as a unit.The coil was replaced with another coil (catalog # cdx18185530/lot unknown).The procedure was successfully completed without further issues or delay with 12 micrus coils and 10 trufill coils.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 time.No visible defect/damage was noted on the products prior to and after the event.The physician commented that cause of the issue may be that the micro catheter was used for over 4 hours, so it might have damaged or the y connector was not used on a routine basis at the site.The products are 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: 5983258
• Report Number: 2954740-2016-00219
• Device Sequence Number: 10783446
• Product Code: HCG
• UDI-Device Identifier: 10878528008696
• UDI-Public: (01)10878528008696(17)200228(10)C33289
• 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): 09/20/2016

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: 02/28/2020
• Device Catalogue Number: CDX18185530
• Device Lot Number: C33289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 09/28/2016
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENPOWERDCB (LOT UNKNOWN)
• Patient Age: 80 YR