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

Catalog Number CPL10015230

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The initial alert date for this complaint was (b)(6) 2015 when damage the resheathing tool was reported.This did not meet criteria for mdr reporting.The device was returned for analysis on (b)(4) 2016, and the analysis that was completed on (b)(4) 2016 revealed there was damage to the actual coil.The device met mdr reportability criteria on (b)(6) 2016 when the coil damage was discovered.The device was returned for analysis.The unidentified microcatheter and the rotating hemostatic valve (rhv) were not returned.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned/rinsed before being returned which may have produced further damage.It is also unknown if the device was improperly handled for returned packaging or was further manipulated and/or inspected post-procedurally.Any trace evidence that may have been complaint related may have been altered or removed prior to being returned.Located off the proximal end at 39.3 centimeters and 68.5 centimeters are two unreported severe kinks and bends to the core wire.The microcoil system was returned fully sheathed with no damage found to the resheathing tool or sheath.As viewed through the introducer sheath, unreported severe compression and buckling coil damage at the proximal section was found.Unreported damage was found to the coil¿s socket ring which was bent distally approximately 90 degrees.No resheathing tool damage was found.The coil was advanced, retracted, and resheathed multiple times with no problems encountered.The circumstances of how and when all the above unreported damage occurred to the microcoil system cannot be determined.No manufacturing defects were found.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.The complaint of the resheathing tool being torn during the resheathing process cannot be confirmed.The microcoil system was returned fully resheathed with no damage found to the resheathing tool or sheath.The root cause of the unreported coil damage could not be determined; however, procedural factors may have contributed to the event.The coil was advanced, retracted, and resheathed multiple times with no problems encountered.In addition, without the identification or the return of the unknown microcatheter and the rhv used in the procedure, it cannot be determined if these components had any contributions to the complaint event.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, the resheathing tool of the deltapaq (cpl10015230/c26795) was torn when the surgeon tried to resheath the coil.There was no potential patient adverse event.Multiple attempts to obtain additional information were unsuccessful.When the device was returned for analysis, the coil was found to be damaged.

• Brand Name: DELTAPLUSH - 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: 5456492
• MDR Text Key: 38876820
• Report Number: 2954740-2016-00046
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K083646
• 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: 10/01/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2019
• Device Catalogue Number: CPL10015230
• Device Lot Number: C26795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1