MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CASHMERE 14 - PLATINUM MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number SRC14030420

Device Problems Bent (1059); Positioning Failure (1158); Premature Activation (1484); Stretched (1601); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/18/2017

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, during a coil embolization of the internal carotid artery, the cashmere coil (src14030420/ p11045) failed to detach and then there was resistance during withdrawal and the coil separated into two pieces in the microcatheter.There had been no resistance during advancement of the coil.The microcatheter was removed with the coil.After the failure to detach, the cable was changed out for another, but there was still no detachment.Upon removing the coil from the patient, it separated in the sl10 microcatheter and was retrieved.The same cables and dcb were used to complete the procedure.A pre-deployment electrical check had been completed and no low battery light was seen and a fault light was not seen.The green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.Here was no patient death or serious injury and no additional medical intervention was needed.The patient was in good condition.It was reported that the device would be returned for analysis.

Manufacturer Narrative

Additional information obtained via product analysis on 9/21/2017: the coil was found to be stretched and bent.As reported by a healthcare professional, during a coil embolization of the internal carotid artery, the cashmere coil (src14030420/ p11045) failed to detach, and then there was resistance during withdrawal and the coil separated into two pieces in the microcatheter.There had been no resistance during advancement of the coil.The microcatheter was removed with the coil.After the failure to detach, the cable was changed out for another, but there was still no detachment.Upon removing the coil from the patient, it separated in the sl10 microcatheter and was retrieved.The same cables and dcb were used to complete the procedure.A pre-deployment electrical check had been completed and no low battery light was seen and a fault light was not seen.The green system ready light illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.Here was no patient death or serious injury and no additional medical intervention was needed.The patient was in good condition.It was reported that the device would be returned for analysis.The device was returned loosely coiled around itself.The introducer was fully unsheathed.The resheathing tool was advanced all the way to the green introducer.The hub was advanced to the resheathing tool.The microcoil was detached and included separately.There is a kink in the dpu core wire at approximately 78.5 cm from its proximal end.There is a slight bend in the distal tip coil.The resistive heating coil did not receive heat and melt the fiber.The embolic coil is stretched in several locations.There is a dark mass, possibly blood, at the proximal end covering the coil ring.The stretch-resistant suture is not present at the proximal end of the embolic coil.The ball tip is present and the suture filament is present at the distal end of the coil.There is a severe kink at the distal end of the coil.The resistance of the dpu was tested, and the multimeter id# (b)(4) was overloaded.The dpu was connected to the enpower control cable and enpower dcb.The system ready light on the detachment control box illuminated.Pressing the detach button initiated the detach cycle, which caused the resistive heating coil to deliver heat.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the embolic coil separated from the dpu was confirmed.Because the embolic coil was separated, the complaint that there was resistance on withdrawal of the dpu could not be tested.The complaint that the embolic coil failed to detach could not be confirmed.The combination of overloaded resistance test and lack of system fault when the dpu was attached to the dcb is unexpected.However, since the detachment cycle could be initiated, it is unlikely that this caused the reported failure to detach.In addition, resistance is inspected in 100% of microcoil systems in-process.A microcoil system that fails resistance would be identified and segregated at this inspection.The appearance of a dark mass, possibly blood, at the end of the coil suggests that there was not a sufficient flush maintained.Insufficient flush could lead to resistance when withdrawing the coil.The ifu cautions to verify flush lines are open and properly pressurized if unusual friction is noticed during advancement or retraction of the microcoil system.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: CASHMERE 14 - PLATINUM 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: 6787713
• MDR Text Key: 83692013
• Report Number: 2954740-2017-00224
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528004103
• UDI-Public: (01)00878528004103(17)200831(10)P11045
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

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: 08/31/2020
• Device Catalogue Number: SRC14030420
• Device Lot Number: P11045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 09/21/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1