MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number DLF180520

Device Problems Positioning Failure (1158); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2017

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.A micro catheter (prowler select plus 45°) and an enpower control cable were also used for this procedure.(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 Description

As reported by a healthcare professional, during treatment of an inferior mesenteric aneurysm, a deltafill18 (dlf180520, s12936) failed to detach.Pre-deployment electrical check was not performed.The deltafill18 was attempted to detached at the lesion and the physician pressed the deployment button, but it was not detached although the signal beep was audible.The button was pressed several times but the issue continued.The coil was successfully removed from the patient and was replaced with another one (unknown lot# and catalog#).The procedure was successfully completed without further issues or delay with 2 coils after replacing the coil.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.No further information was available.

Manufacturer Narrative

(b)(4) updated since analysis found that the coil was kinked.As reported by a healthcare professional, during treatment of an inferior mesenteric aneurysm, a deltafill18 (dlf180520, s12936) failed to detach and the coil was returned in a kinked condition.Pre-deployment electrical check was not performed.The deltafill18 was attempted to detached at the lesion and the physician pressed the deployment button, but it was not detached although the signal beep was audible.The button was pressed several times, but the issue continued.The coil was successfully removed from the patient and was replaced with another one (unknown lot# and catalog#).The procedure was successfully completed without further issues or delay with 2 coils after replacing the coil.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.No further information was available.The returned device is fully unsheathed, and the embolic coil is tangled around the translucent introducer sheath.The embolic coil was gently untangled from the translucent introducer sheath.There is blood in the translucent introducer sheath.There are bends in the device positioning unit (dpu) core wire approximately 55 cm, 78 cm, 82 cm, and 131 cm from the proximal end.The ball tip is intact.The embolic coil is kinked.The articulating joint is damaged.The resistance heating (rh) coil has not received heat.The v-notch of the resheathing tool is fractured.The resistance of the device was measured, and resistance was 50.9, which is within the specification range of 48.5 ¿ 56.The device was connected to a lab sample detachment control box dcb2000500 (dcb2) with enpower connecting cable, and the power was turned on.The system ready light illuminated.The embolic coil was immersed in warmed enzyme solution and a detach cycle was initiated.The embolic coil detached.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 embolic coil failed to detach is not confirmed.The embolic coil detached under laboratory conditions.Without the return of the connecting cable and dcb2 used during the event, the cause of the reported complaint cannot be determined.The damage to the resheathing tool indicates that the device was not properly unlocked.The ifu instructs the user to unlock the device by gently pulling the clear tab of the introducer sheath out and away from the re-sheathing tool at a 45-degree angle.Pulling the tab straight out (in parallel to the dpu) will result in damage to the resheathing tool, and may cause damage to the embolic coil.The bends in the dpu core wire are evidence of application of excessive force, possibly in an attempt to overcome resistance.Such force could have also resulted in the kinked embolic coil and damaged articulating joint.Resistance may have been felt as a result of insufficient flush.The presence of blood in the translucent introducer sheath 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 review of complaint history for the device.Since there was no evidence to suggest the events were related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: DELTAFILL18
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; rue girardet 29; le locle jura ; SZ
• Manufacturer Contact: joaquin kurz ; 821 fox lane; san jose, CA 95131 ; 9497899383
• MDR Report Key: 6913961
• MDR Text Key: 89639915
• Report Number: 2954740-2017-00281
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10886704076926
• UDI-Public: (01)10886704076926(17)191130(10)S12936
• 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,Followup
• Report Date: 09/11/2017

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: 11/30/2019
• Device Catalogue Number: DLF180520
• Device Lot Number: S12936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 10/04/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1