MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 18 - CERECYTE MICROCOIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number PC418175030

Device Problems Kinked (1339); Stretched (1601); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

The customer name could not be obtained.Mfg name - codman & shurtleff, inc.Dba depuy synthes products, inc.This file met mdr reporting when it was found that the coil was kinked and stretched during product analysis on 10/25/2017.Conclusion: presidio 18 lot c29738 was returned for analysis.There is evidence of blood in the green introducer.The distal end of the embolic coil is located in the proximal portion of the green introducer.There is blood in the translucent introducer sheath along the length of the embolic coil.The embolic coil passes through the resheathing tool; it protrudes from the translucent introducer sheath on the distal side of the resheathing tool and is tangled around the proximal end of the resheathing tool.The exposed embolic coil is stretched.There are no kinks or bends apparent in the dpu core wire.The ball tip is intact.The embolic coil is kinked.The protruded embolic coil is stretched and kinked, and the suture fiber is missing.The embolic coil passes through the resheathing tool and is stretched and tangled around the proximal side of the resheathing tool.There is some plastic remodeling of the sides of the v-notch on the resheathing tool.The articulating joint is damaged.A review of manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection processes related to the reported complaint.A nonconformance was generated when it was determined that the pga suture was subject to degredation from ambient moisture.Product was reworked by replacing the suture and released.All product rejected during manufacturing was identified as scrap and properly accounted for.The complaint of positioning difficulty cannot be confirmed because the embolic coil is damaged and tangled around the resheathing tool.The complaint of prescore rupture is confirmed.The embolic coil protrudes from the translucent introducer sheath distal to the resheathing tool.Blood found on the embolic coil, in the green introducer, and in the translucent introducer sheath suggest that 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.Resistance from blood in the translucent introducer sheath could result in positioning difficulty.The kink observed in the embolic coil indicates that excessive force was applied, possibly in an attempt to overcome resistance.Finally, the fact that the resheathing tool passes over the embolic coil, and that the embolic coil is tangled around it, indicates that the device was unsheathed over the embolic coil.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 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.Damage to the articulating joint could have occurred either as a result of the excessive force, or as a result of passing the resheathing tool over the embolic coil.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 events was related to a manufacturing issues, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

As reported by a healthcare professional, a presidio 18 coil (pc4181750-30, c29738) was difficult to position in the splenic artery aneurysm and the sheath introducer was damaged during attempt to re-sheath, and a presidio 18 (pc418164730/ c15917) loop protruded into the parent vessel and could not be re-sheathed.Lot c29738 was attempted to be place in the aneurysm, but it kicked back strongly.Therefore, the physician tried to re-sheath the coil, but the sheath introducer became damaged and could not re-sheath the coil.The coil was replaced with another one.Lot c15917 was used for the 3rd coil, but the loop was out of the mother vessel from the neck and the coil could not be placed.Therefore, the physician tried to re-sheath, the coil, but the coil was could not be re-sheathed.It was replaced with another one.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.It was reported that only lot c29738 was available for investigation.No further information was available.

• Brand Name: PRESIDIO 18 - 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: 6977802
• MDR Text Key: 90851990
• Report Number: 3013875781-2017-00016
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528003298
• UDI-Public: (01)00878528003298(17)190831(10)C29738
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002056
• 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
• Report Date: 08/07/2017

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: 08/31/2019
• Device Catalogue Number: PC418175030
• Device Lot Number: C29738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2017
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1