MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; CNV DCS COILS

Catalog Number PC410041230

Device Problems Stretched (1601); Separation Failure (2547); Deformation Due to Compressive Stress (2889)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

This is one of two initial mdr reports submitted for this complaint with associated mfr report# 2954740-2016-00096.(b)(4).The product is available for evaluation and testing, however the analysis has not been completed.A device history record review is currently being conducted and the results are not yet available.Additional information will be submitted within 30 days of receipt.No conclusions are made at this time.

Event Description

As reported by a health professional, during coil embolization of a previously un-ruptured aneurysm at the right middle cerebral artery aneurysm two coils failed to detach.During the procedure the physician was unable to detach the second coil used, presidio coil ((b)(4)).Physician tried detaching the coil four times but still failed, which caused a half hour delay.During the process of detaching the coil, hemorrhage was confirmed through angiography.The surgeon withdrew the coil and used a new coil.Another coil deltapaq cere ((b)(4)) also failed to detach during the procedure.The coil was withdrawn and a new coil was used to complete the procedure.Both the coils were still attached to the delivery system upon removal and no damages were noted on the coils.The patient is reported to be in stable condition.No further information is available.

Manufacturer Narrative

This is one of two final mdr reports submitted for this complaint with associated mfr report# 2954740-2016-00096.(b)(4).Very limited information was received.Both the unidentified detachment control box (dcb) and the connecting cable were not returned.The unidentified microcatheter was 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.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.Located 1.2 centimeters off the distal tip of the device positioning unit (dpu) is a buckled area of the grey tip coil section.The coil could not be advanced outside the distal tip of the green introducer without the use of ultrasonic bath.The proximal section of the coil has two sections of severe compression and buckling damage.The coil¿s socket ring has been pushed down inside the outer sheath (angle ring section) and against the resistive heat coil section.The articulating junction is now in the fixed position.There is now a loss of concentricity between the distal tip of the dpu and the proximal end of the coil.Tension was applied to the detachment fiber for inspection purposes.The detachment fiber was found to be intact, undamaged, and no heat was found to have melted the fiber.Past the damaged proximal section of the coil, the remainder of the coil was found to be undamaged.The locking mechanism has compression and stretching damage.No manufacturing defects were found.The device positioning unit (dpu) passed electrical testing with resistance at 51.8 ohms (range 48.5/56.0) and the enpower and cable systems ready green light illuminated (ifu).The coil detached on the first detachment cycle post-detachment inspection found that the enpower systems ready green light remained illuminated and the resistance passed at 51.8 ohms.Post-detachment inspection found that the detachment fiber received heat and melted as designed.The field complaint of the coils non-detachment could not be duplicated.No manufacturing defects were found.The circumstances of how and when all the unreported damage found above, but not reported in the complaint event occurred cannot be determined.It should be noted that the majority of the unreported damage cannot be seen by the unaided eye.The complaint of the coils non-detachment cannot be confirmed.The dpu passed electrical testing and the coil detached on the first detachment cycle, therefore the root cause of the coils non-detachment cannot be determined.In addition, without the return of the complete detachment system and the unidentified microcatheter used in the procedure, it cannot be determined if these components contributed to the complaint event.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 presidio (pc410041230/c30944) coil's non-detachment cannot be confirmed.The dpu for the coil passed electrical testing and the coils detached on the first detachment cycle, therefore the root cause of the reported event cannot be determined.There is no evidence from the dhr review of any manufacturing issues related to the complaint.Review of the information does not suggest what factors may have contributed to the reported event.Since there was no evidence of a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: PRESIDIO 10 - 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: 5612971
• MDR Text Key: 43840741
• Report Number: 2954740-2016-00095
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K002056
• 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: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: PC410041230
• Device Lot Number: C30944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR