MAUDE Adverse Event Report: CASH 14 PLAT COIL 6MMX15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	SRC140615-20
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This device met mdr reporting criteria on 01/16/2018 when it was found during product analysis that the coil was kinked.Information about patient age, weight, and medical history were not provided.(b)(4).Conclusion: the device was returned in its inner pouch.Labeling on the inner pouch matches the product documented in the complaint.Approximately 0.5 cm of the distal end of the embolic coil is advanced out of the green introducer.The proximal end of the embolic coil passes into the resheathing tool.Approximately 2.5 cm of embolic coil is protruding from the skive of the translucent introducer sheath distal to the resheathing tool.There are no apparent kinks or bends in the device positioning unit (dpu) core wire.The ball tip is intact.There is blood on the embolic coil.The embolic coil is kinked.The embolic coil protrudes from and is anchored in the skive of the translucent introducer sheath.The embolic coil is kinked at the point of protrusion.The solder ring at the proximal end of the embolic coil is just visible exiting the distal end of the resheathing tool.There is blood on the resheathing tool.There is a very slight fracture to the v-notch of the resheathing tool.An attempt was made to pull back the resheathing tool to expose the articulating joint and resistance heating (rh) coil.The resheathing tool could not be moved.Since the embolic coil is anchored in the skive of the translucent introducer sheath, it cannot be advanced out of the introducer.Since the embolic coil cannot be advanced out of the introducer, advancement through a microcatheter cannot be tested.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 resheathing tool was broken is not confirmed.The resheathing tool is in one piece.The complaints that the introducer is damaged and that there is rezipping difficulty are confirmed.The embolic coil is protruding from the skive of the translucent introducer sheath distal to the resheathing tool and is anchored in the skive.The resheathing tool cannot be advanced or retracted, and the embolic coil cannot be resheathed.The resheathing tool is passing over the distal end of the dpu and the proximal end of the embolic coil.The ifu (lcn 51844-001 rev.B) 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 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 will be unsheathed and pass through the resheathing tool.This can cause damage to the embolic coil and can also cause it to protrude from the introducer.The presence of blood on the embolic coil suggests that an insufficient flush was maintained.The ifu states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the device.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is an initial/final mdr report.
Event or Problem Description
As reported by a healthcare professional, during coil embolization of a ruptured ophthalmic artery aneurysm, a cashmere coil (src14061520 / p11734) could not be advanced through the excelsior sl-10 microcatheter and stretched when it was pulled back.Both the coil and microcatheter were removed from the patient.A continuous flush had been maintained through the microcatheter.The coil did not detach or separate in the microcatheter.Another cashmere (src14061520 / p10614) could not be re-sheathed because the peel-away part of the introducer sheath was damaged and the coil was found to be kinked during product analysis.There had been no difficulty during unsheathing the device.Both devices had been prepped and used as per the instructions for use (ifu).There were no patient consequences due the events.No further details were available.

• Brand Name: CASH 14 PLAT COIL 6MMX15CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• MDR Report Key: 7218048
• Report Number: 2954740-2018-00502
• Device Sequence Number: 158394
• Product Code: KRD
• UDI-Device Identifier: 00878528004011
• UDI-Public: (01)00878528004011(17)200531(10)P10614
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K022420
• 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
• Report Date (Section B): 11/06/2017

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: 05/31/2020
• Device Model Number: SRC140615-20
• Device Catalogue Number: SRC14061520
• Device Lot Number: P10614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1