MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAXTRASOFT COIL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number DLX100206

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.Concomitant medical products: a guidewire(chikai 200, asahi intecc), a guising catheter (roadmaster 6fr 90, goodman), a micro catheter (sl10 45°, stryker), a balloon catheter (4mm*10mm shouryu), a y connector (black y connector) and an enpower cable were also used for this procedure.(b)(4).Customer information could not be obtained.This event met mdr reporting criteria on 10/25 it was confirmed that the coil was kinked.Conclusion: lot s12220 was returned for analysis.There is blood in the end of the green introducer and throughout the translucent introducer sheath.The embolic coil is located in the translucent introducer sheath; the proximal end of the embolic coil and the distal end of the dpu have protruded from the skive of the translucent introducer sheath.There are bends in the dpu core wire at approximately 10.5 cm, 100 cm, and 113 cm from the proximal end.The translucent introducer sheath has been kinked after passing through the resheathing tool.Microscopic images of blood at the end of the green introducer and in the translucent introducer sheath.The ball tip is somewhat obscured by the translucent introducer sheath, but appears to be intact.The articulating joint is damaged.The rh coil has not received heat and melted.The embolic coil is kinked and has blood on it at the point of protrusion.The dpu core wire and resheathing tool show the presence of blood; the v-notch of the resheathing tool is undamaged.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 because outer diameter (od) of the resistance heating (rh) coil assembly was not inspected during product final inspection.Health hazard evaluation (see 103304912 rev.1) concluded that the primary risk of the rh coil od being out of specification is that the end user would experience friction while advancing or retracting the device through a microcatheter.In addition, statistical evaluation in the hhe indicated that product in the field should be within specification, even though the required inspection was not conducted.Based on the results of the hhe product was released as acceptable.The complaint that the device had protruded from the translucent introducer was confirmed.The complaint that the device is impeded from advancing through a microcatheter cannot be confirmed because of the protrusion and damage to the embolic coil.However, the presence of blood in the green introducer, in the translucent introducer sheath, and on the embolic coil suggest that resistance to advancement may have been observed.Blood in the introducer is indicative of insufficient flush.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.Application of excessive force while attempting to advance the coil against resistance can cause the bends observed in the dpu core wire.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 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.Finally, the kinks in the proximal end of the translucent introducer sheath suggest that the user bent the translucent introducer sheath sharply during the act of unsheathing.The ifu directs the user to fold the proximal end of the introducer sheath gently and grasp it and the resheathing tool in the thumb and forefinger while advancing the embolic coil into the microcatheter.If the translucent introducer sheath develops a sharp kink, it is likely to be unable to pass through the resheathing tool, or if it does, it would be unable to re-enclose the dpu, causing protrusion.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

During coil embolization of an ic-ophthalmic and ic paraclinoid aneurysm, a deltaxsft10 (dlx100206/ s12220) became stuck in the microcatheter and during re-deployment the introducer split open, and deltaxsft10 (dlx100152, s12418) marker was out of position.Lot s12220 was selected for the 5th coil.The physician pushed the introducer into the microcatheter as usual and attempted to insert the coil system, but the coil could not be inserted into the microcatheter smoothly and the coil was stuck in the y connector.The coil was restored in the introducer and the coil was redelivered, but the introducer was split open at the middle of the delivery wire.The coil was replaced with a competitor¿s coil.It was confirmed that the microcatheter was properly flushed before delivery of the coil system into the micro catheter.After framing with the coil, complaint coil lot s12418 was selected.It was in the state that the black y connection was connected to the microcatheter (sl10 45 preshape).After the device was prepared, marker point was checked in front of the black y connector.The physician reported that one third of the embolic coil had already been forward into the aneurysm when he checked the marker position at the front of the y connector; however, it was unknown if the marker position was in front of the y connector or forward through the y connector.It was confirmed that there was no aneurysm rupture.Since the tip of the microcatheter was located away from the aneurysm wall, the physician judged that there was no problem, the coil was placed as it was.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.The product will be returned for investigation.No further information was available.

• Brand Name: DELTAXTRASOFT COIL
• 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: 6977650
• MDR Text Key: 90904833
• Report Number: 3013875781-2017-00015
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704077336
• UDI-Public: (01)10886704077336(17)190930(10)S12220
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150319
• 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: 08/03/2017

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: 09/30/2019
• Device Catalogue Number: DLX100206
• Device Lot Number: S12220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1