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

Catalog Number CPL10015330

Device Problem Difficult To Position (1467)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

Event Type  malfunction  

Manufacturer Narrative

This is initial/final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00062.(b)(4).The deltaplush will not be returned, therefore the root cause of the positioning difficulty and the resheathing failure 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.Therefore no corrective actions will be taken at this time.

Event Description

As reported by a healthcare professional, during the procedure a deltaplush cerecyte coil 1.5mm x 3cm failed to resheath.The coil was the fourth coil being used for the procedure.The physician did not like the shape of the coil deployment and decided to pull it out, however the coil introducer failed to re-sheath.The physician used a same like product to complete the procedure successfully.There were no adverse events or patient injuries reported due to the reported event.It was initially reported that the complaint product is available for return.

Manufacturer Narrative

This is final mdr report being submitted for this complaint with associated mfr# 2954740-2017-00062.As reported by a healthcare professional, during the procedure a deltaplush cerecyte coil 1.5mm x 3cm failed to resheath.The coil was the fourth coil being used for the procedure.The physician did not like the shape of the coil deployment and decided to pull it out, however the coil introducer failed to re-sheath.The physician used a same like product to complete the procedure successfully.There were no adverse events or patient injuries reported due to the reported event.It was initially reported that the complaint product is available for return.Update 31mar2017: the procedure was coiling of an anterior communicating artery aneurysm; the vessel was not tortuous.The size of the coil was not appropriate for the aneurysm.There were no damages noted on any part of the coil or the coil delivery system prior to use or upon removal.There was no resistance when the coil was advanced, repositioned or withdrawn.Only the coil was removed from the patient, the reported event did not require the removal of the catheter.An adequate continuous flush was maintained through the catheter.Concerning cleanliness only, the microcoil system was returned in almost pristine condition.The system was either not used or was cleaned by the end user/hospital 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.In addition, any trace or other evidence that may have been complaint related may have been altered or removed prior to being returned due to post-procedural handling, cleaning, and packaging.All location and measurement callouts are approximate and for reference only.Located 29.0 centimeters off the proximal end is an unreported kink to the device positioning unit (dpu).Located 25.0 centimeters off the distal tip of the green introducer is unreported protrusion of the dpu through the sheath.No mechanical sheath damage was found at the protrusion site.No manufacturing defects were found.The circumstances of how and when all the unreported damage occurred cannot be determined.The complaint of the re-sheathing difficulty is confirmed.While the root cause cannot be determined due to the unreported damage found and from the complaint statement, ¿¿there were no damages noted on any part of the coil or the coil delivery system prior to use or upon removal¿¿ the evidence as received suggests that the kinked dpu may have protruded through the introducer sheath causing the inability of the unit to be completely re-sheathed.The circumstances of how and when this damage occurred cannot be determined as it was stated no damages were found to the device after the procedure.The complaint of the positioning difficulty cannot be confirmed.While the exact root cause cannot be determined, the most likely contributing factor was stated in the complaint event by the physician, ¿¿the size of the coil was not appropriate for the aneurysm.There were no damages noted on any part of the coil¿¿ therefore, the most likely contributing factor to the positioning difficulty was the incorrect coil size chosen for the target site¿s dimension at that exact time frame during the procedure.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 re-sheathing difficulty is confirmed.The root cause could not be determined; however, the information and analysis suggests that the kinked dpu protruding out of the introducer sheath possibly contributed to the failure.The complaint of the positioning difficulty cannot be confirmed, the possibly contributing factor to this failure was that the incorrect size coil was chosen for the target size¿s dimension during the procedure.Review of 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.Product returned for analysis 10apr2017.

• Brand Name: DELTAPLUSH - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• 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: 6428217
• MDR Text Key: 70762874
• Report Number: 2954740-2017-00062
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: (01)00878528008194(17)210430(10)S10575
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: CPL10015330
• Device Lot Number: S10575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1