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

Catalog Number CDF10015430

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2015

Event Type  malfunction  

Manufacturer Narrative

This event was originally received on 12/29/2015; however, the event met the criteria for mdr reporting on 05/02/2016 when the analysis was completed and coil damage was confirmed.(b)(4).Conclusion: the deltapaq 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.Located off the proximal end of the resheathing tool are kinks on the core wire at 1.0, 2.0, & 5.0 all in centimeters.The coil could not be advanced out of the sheath and had to be removed by dissection.The coil¿s socket ring has been pushed down inside the outer sheath.The proximal end of the coil is severely compressed and buckled.The remainder of the coil is undamaged.The locking mechanism has indentation, compression, and stretching damage.No manufacturing defects were found.A review of the manufacturing documentation associated with this lot (c35822) presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint of the resheathing difficulty was confirmed.The most likely root cause of the resheathing difficulty may have occurred when the microcoil system was first unlocked for use and the sheath was retracted straight back instead of up at a forty-five degree angle and then back.When the sheath was pulled straight back, the locking mechanism caught the inside of the v notch of the resheathing tool and became embedded.In addition, the locking mechanism may not have been fully disengaged off the core wire.The sheath also caught the v notches extended edges.This produced a binding action between the device positioning unit (dpu), the sheath, and the coil.This binding action produced significant resistance which produced multiple core wire kinking, pushed the coil¿s socket ring down inside the outer sheath, caused severe compression and bucking damage to the proximal end of the coil, and prevented the coil from advancing.In this condition the coil cannot be resheathed.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿hold the introducer sheath (loosely-looped) in the left hand.Keeping the introducer tip near the re-sheathing tool, grasp the distal end of the re-sheathing tool between your left thumb and forefinger.Grasp the clear tab near the end of the introducer sheath body with the thumb and forefinger of your other hand.Gently pull the clear tab of the introducer sheath out and away from the re sheathing tool at a 45-degree angle to unlock the microcoil.Continue to pull the tab until an additional 0.5 to 1.0 inches (1.3 to 2.5 cm) of the translucent material is exposed.Gently fold the translucent tab towards the distal end, and firmly grasp the distal end of the re sheathing tool and the translucent tab between your thumb and forefinger.Caution: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the locking mechanism, or clear tab is unlocked and pulled out from the resheathing tool approximately 1in.(2-3cm).¿ in addition, without the return of the unidentified microcatheter and the rotating hemostatic valve (rhv) used in the procedure, it cannot be determined if these components contributed to the complaint event.There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, a deltapaq coil (cdf10020230/c27992) had a re-sheathing failure issue and during product analysis, it, it was determined the coil was compressed and buckled.There were no potential patient adverse events.Three attempts to obtain additional information were unsuccessful.

• Brand Name: DELTAPAQ - CERECYTE MICROCOIL
• Type of Device: CNV DCS COILS
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 5627390
• MDR Text Key: 44360168
• Report Number: 2954740-2016-00101
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K080437
• 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: 12/29/2015

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: 05/31/2020
• Device Catalogue Number: CDF10015430
• Device Lot Number: C35822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2016
• Initial Date FDA Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1