MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number UNK-CNV DCS COILS

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

This is one of one initial mdr report being submitted for this complaint with associated mfr# 2954740-2016-00231.Additional procode: krd.Udi unavailable, catalog# and lot# unknown.The product will not be returned for analysis however a device history record review is currently being conducted and the results are not yet available.No conclusion is made at this time.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a health care professional, during stent assisted coil embolization for treatment of endoleak strong resistance was experienced when an unknown coil (deltamaxx or presidio 18) was being inserted into an unknown sheath introducer and could not be advanced, the coil was the fourth or the fifth coil used for the procedure.The coil was removed from the unknown microcatheter and the introducer sheath was checked, a foreign substance was found at its distal tip.The substance was pushed out of the sheath; the coil was then inserted without resistance and implanted.It is unknown which coil (deltamaxx or presidio 18) had the issue.The procedure was successfully completed with 19 coils (cnv products) without further issues or delay.There were no patient injuries or complications.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and a constant flush was maintained at all times.No visible defect or damage was noted on the products prior to and after the event.The foreign substance will be returned for investigation.The patient information is unknown.Information on the other devices used in the procedure is not available.No further information is available.

Manufacturer Narrative

This is follow-up mdr report being submitted for this complaint with associated mfr# 2954740-2016-00231.The device was not returned, however the particle found in the introducer sheath was returned on 04oct2016.Very limited information was received.The unknown microcoil system, the unidentified microcatheter, and the rotating hemostatic valve (rhv) were not returned.The foreign substance is a blood and protein mixture.The complaint of the resistance during introduction and the foreign substance on the distal tip of the introducer sheath is not confirmed.The foreign substance is a protein and blood mixture originating most likely from the patient.While the root cause of the resistance cannot be determined as the unknown microcatheter, the unidentified microcoil system including the introducer sheath was not returned, and the coil was implanted, the most likely contributing factor that produced the resistance and the blood/protein obstruction may have been the lack of a constant pressurized flow of an appropriate flush solution.For optimum product performance and to prevent potential complications, the instructions for use (ifu) recommends, ¿to achieve optimal performance of the codman microcoil system, it is important that a continuous infusion of an appropriate flush solution be maintained.Figure 2 illustrates the connections necessary for the codman microcoil delivery system including a typical continuous saline flush set up with pressure bag for the catheter systems.¿ in addition, without the return of the unidentified microcoil system, the unknown microcatheter, and the rhv mused in the procedure, it cannot be determined if these components had any contributions to the complaint event.The manufacturing records could not be reviewed as the lot number was unknown.The complaint of the resistance during introduction and the foreign substance on the distal tip of the introducer sheath is not confirmed.While the root cause of the resistance cannot be determined as the unknown microcatheter, the unidentified microcoil system including the introducer sheath were not returned, and the coil was implanted, procedural and handling factors were the most likely contributing factors.The product was not returned for analysis and a device history record review cannot be completed because the lot for the product is unknown.Since the event could not be confirmed and there is no evidence of a manufacturing-related malfunction, no corrective actions will be taken at this time.

• 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: 6013423
• MDR Text Key: 56980980
• Report Number: 2954740-2016-00231
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK-CNV DCS COILS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN SHEATH INTRODUCER