MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAMAXX - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number CDX18124230

Device Problems Electrical /Electronic Property Problem (1198); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: deltamaxx (cdx181242/c34489), presidio (pc418124040/c28508), andprowler select plus microcatheter (pc418124040/c28508) were used for the procedure.Information regarding patient age, gender, and weight were not available.No additional information could be obtained.(b)(4) complaint conclusion: the deltamaxx was not returned for analysis.A review of the manufacturing documentation associated with this lot (c34489) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The failure to detach the deltamaxx using the enpower cable and the resistance within the prowler select plus could not be confirmed without product return for analysis.The root cause of the events could not be determined; however, procedural/handling factors may have contributed to the events.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, during coil embolization of the right internal iliac artery, the green system ready light did not illuminate when a deltamaxx (cdx181242/c34489) was connected with a enpower cable (lot unknown) without need for excessive force, although the pre deployment electrical check had been successful.Also during the procedure, the physician experienced resistance when a presidio (pc418124040/c28508) was advanced through a prowler select plus (606s255fx / 17236308).The same prowler select plus had been used with the deltamaxx coil, without resistance.The deltamaxx was replaced with another coil, with which the light illuminated successfully.The resistance with the presidio was felt at 10 cm from distal end of the prowler select plus microcatheter (catalog/lot unknown).The presidio was replaced, and an additional 10 coils were successfully implanted with slight resistance felt between the coils and microcatheter.The procedure was completed without further issues using the same connecting cable and detachment control box, but due to the event it was extended for 3 minutes.Nevertheless the event was not clinically significant as there were no patient injuries or complications.The complaint products were stored per labeling instructions.The procedure was conducted in accordance with the ifu.The constant flush had been maintained at all times.No visible damage was noted prior to or after the event.The products were already discarded by the customer.No further information was available.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: kimberly soter ; 821 fox lane; san jose, CA 95131 ; 5088288310
• MDR Report Key: 5331663
• MDR Text Key: 34609771
• Report Number: 2954740-2015-00285
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120274
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: CDX18124230
• Device Lot Number: C34489
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1