MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number PC410041230

Device Problems Kinked (1339); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

This initial/final mdr will be the only report submitted for mfr report #3013875781-2018-00002.This event was deemed reportable based on the device evaluation findings of the presidio10 4x11.5 coil (pc410041230/s10946).(mfg name): codman & shurtleff, inc.Dba depuy synthes products, inc.Conclusion: image of the device as returned.The distal end of the embolic coil is located in the middle of the green introducer.The embolic coil is stretched.The proximal end of the embolic coil, along with the articulating joint, resistance heating (rh) coil, and distal end of the extended coil protrude from the skive of the translucent introducer sheath.The tip coil section of the device positioning unit (dpu) passes through the resheathing tool; a segment of the tip coil has protruded from the skive of the translucent introducer sheath distal to the resheathing tool.There are bends in several locations along the length of the dpu core wire.The ball tip is intact.There is blood on the embolic coil.The green introducer is pinched.The embolic coil is damaged at the point where the introducer is damaged.Microscopic image of the stretched embolic coil.The articulating joint is damaged.There is blood on the resistance heating (rh) coil.The section of extended coil that has protruded from the skive of the translucent introducer sheath is kinked.Microscopic image of the distal end of the protruded tip coil.The v-notch of the resheathing tool is undamaged.The device cannot be resheathed because the embolic coil and tip coil both protrude from the skive of the translucent introducer sheath.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint that the device cannot be resheathed is confirmed.The protrusion of the embolic coil and parts of the dpu from the skive of the translucent introducer sheath, along with bends in the dpu core wire, prevent the translucent introducer sheath from re-forming during the resheathing operation.The damage to the dpu core wire and embolic coil are evidence that excessive force was applied to the device, possibly in an attempt to overcome resistance.Resistance could have been felt as a result of over-tightening of the rotating hemostatic valve (rhv), or as a result of insufficient flushing.The damage to the green introducer (and concomitant kink in the embolic coil) indicate that the rhv was over-tightened at this location.The ifu cautions against over-tightening the rhv around the introducer, as it may damage the introducer and/or the embolic coil.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.Finally, it is also likely that the resheathing tool was advanced over the embolic coil while unsheathing the device.The 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 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 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.There were no significant safety signals identified related to the reported event based on a review of complaint history for the device.Therefore, no corrective actions will be taken at this time.

Event Description

It was reported by a healthcare professional that, during a procedure, a presidio10 7x30 coil (pc410073030/c41431) could not be advanced through the microcatheter and a presidio10 4x11.5 coil (pc410041230/s10946) could not be re-sheathed.The physician used another of the same size coils to successfully complete the procedure.

• Brand Name: PRESIDIO 10 - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 47709 freemont blvd; freemont, CA 94538 ; 9497899383
• MDR Report Key: 7161955
• MDR Text Key: 96483972
• Report Number: 3013875781-2018-00002
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003007
• UDI-Public: (01)00878528003007(17)210531(10)S10946
• Combination Product (y/n): N
• PMA/PMN Number: K082739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/14/2017

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: 05/31/2021
• Device Catalogue Number: PC410041230
• Device Lot Number: S10946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Manufacturer Received: 01/03/2018
• Initial Date FDA Received: 01/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1