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

Catalog Number	CRC14030630
Medical Device Problem Codes	Positioning Failure (1158); Material Separation (1562); Stretched (1601); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The device has been returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
As reported by a healthcare professional, during the procedure, the cashmere 14 (crc14030630/ c30942) could not be advanced via the unspecified microcatheter.They withdraw the coil and found it was stretched.They used another coil to complete the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
Additional information received 12 nov 2017: the product was a presidio (b)(4) instead of a cashmere coil.Device codes updated based on analysis results of coil tip separated.The device was returned with an inner pouch.While the item number matches the product documented in the complaint, the lot number on the inner pouch does not match.The lot number on the inner pouch is c28357.The device was returned with the complaint detail report for this complaint, confirming that the returned device is the correct device for this complaint.Review of manufacturing documentation demonstrates that lot c30942 is for a presidio product, catalog #pc4100517-30.Since lot c30942 is not associated with the product documented in the complaint and lot c28357 is, the investigation will consider the complaint product to be lot c28357.The distal end of the embolic coil is located in the translucent introducer sheath.The embolic coil and device positioning unit (dpu) have protruded from the skive of the translucent introducer sheath.There are bends at several locations along the dpu core wire.The resheathing tool is broken.There is some dark-colored contamination on the translucent introducer sheath near the junction with the green introducer.The ball tip of the embolic coil is missing.The embolic coil is kinked.The articulating joint and resistance heating (rh) coil are obscured by the translucent introducer sheath.The extended coil has protruded from the translucent introducer sheath.Because of the protrusion of the extended coil, the embolic coil cannot be advanced out of the introducer to visualize the articulating joint and rh coil.While the resheathing tool is broken, its v-notch is undamaged.The length of the embolic coil was measured with ruler 70007-02ex.The embolic coil was 6.5 cm long, which is within the specification range of 6.0±0.5 cm for this device per (b)(4) rev.5.Advancement of the embolic coil cannot be attempted because the extended coil has protruded through the skive of the translucent introducer sheath.A review of manufacturing documentation associated with lot c28357 presented no issues during the manufacturing or inspection processes related to the reported complaint.The complaint that the device was impeded in the microcatheter cannot be confirmed.The protrusion of the embolic coil prevents advancement of the embolic coil out of the introducer and into a microcatheter.The complaint that the device was unraveled or stretched is not confirmed.While the ball tip of the embolic coil is missing and the device is kinked, there are no stretched sections of embolic coil present.The embolic coil measures within its specification length, so it is unlikely that the ball tip end of the device was stretched and broken off.Bends in the dpu core wire, the broken resheathing tool, and damage to the embolic coil are all indications that excessive force was applied to the device, possibly in an attempt to overcome resistance.It is likely that the resheathing tool was advanced over the extended coil while unsheathing the device.The instructions for use (ifu) instructs the user to unsheathe a small length of the dpu to unlock the device, then to advance the embolic coil into the microcatheter until the hub connector of the dpu reaches the proximal end of the resheathing tool.This results in the placement of the embolic coil and the more delicate and flexible sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing the embolic coil into the microcatheter, there is a risk that the embolic coil, extended coil, or tip coil will be unsheathed and pass through the resheathing tool.This can cause damage to these parts and can also cause them to protrude from the introducer.Once the extended coil had protruded from the skive of the translucent introducer sheath, it would not have been possible to advance the embolic coil out of the introducer or through a microcatheter.100% of devices are inspected in-process for damage to the coil, including kinks, stretched sections, and presence of the ball tip.In addition, advancement and retraction of the coil through the introducer are tested for 100% of devices in-process per the same procedure.Thus, it is unlikely that the embolic coil was damaged when it left the manufacturing facility.Since the exact sequence of events is unknown, it cannot be determined whether the damage to the embolic coil occurred prior to use (in transit, during storage, or when it was being prepared for use) or during the procedure.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 - CERECYTE MICROCOIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• MDR Report Key: 6849440
• Report Number: 2954740-2017-00258
• Device Sequence Number: 13853157
• Product Code: HCG
• UDI-Device Identifier: 00878528004448
• UDI-Public: (01)00878528004448(17)191130(10)C30942
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K072173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: CRC14030630
• Device Lot Number: C30942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 11/12/2015
• Initial Report FDA Received Date: 09/07/2017
• Supplement Report FDA Received Date: 11/15/2017
• Patient Sequence Number: 1