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

Catalog Number CDX18083530

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2017

Event Type  malfunction  

Manufacturer Narrative

Procode: krd/hcg.Concomitant medical products: sheath introducer (terumo), a guide wire (traxcess¿, terumo), a guiding catheter (envoy), a micro catheter (prowler select plus), a y connector (goodman) and an enpower.The device was 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 health care professional, from the beginning, resistance was felt between the 0.014 proxes guidewire and the prowler select plus (606s155fx/ 17474090), so it was replaced with another microcatheter.A deltamaxx (cdx18041530/s10982) did not fit the lesion, so the physician tried to re-sheath the coil; however, the pre-score peel was broken.Excessive force had not been applied.The device was used and prepped as per the ifu.Then a deltamaxx (cdx18083530/ s10592) was attempted to be detached with an enpower control cable (ecb00018200/s13060), but the coil could not detach.Furthermore, the system ready light had gone off at the fourth detachment attempt; therefore, the cable was replaced with another one.The light remained off, so the coil was removed.The procedure was successfully completed without further issues using the replacement cable.However, due to the event, it was delayed for 10 minutes.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 further information was available.

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

(b)(6).

Manufacturer Narrative

Conclusion: as reported by a health care professional, from the beginning, resistance was felt between the 0.014 proxes guidewire and the prowler select plus (b)(4), so it was replaced with another microcatheter.A deltamaxx (b)(4) did not fit the lesion, so the physician tried to re-sheath the coil; however, the pre-score peel was broken.Excessive force had not been applied.The device was used and prepped as per the ifu.Then a deltamaxx (b)(4) was attempted to be detached with an enpower control cable (b)(4), but the coil could not detach.Furthermore, the system ready light had gone off at the fourth detachment attempt; therefore, the cable was replaced with another one.The light remained off, so the coil was removed.The procedure was successfully completed without further issues using the replacement cable.However, due to the event, it was delayed for 10 minutes.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 further information was available.The deltamaxx coil (lot s10592) microcoil system was returned with the dpu core wire tied around itself in a tangled fashion.The enpower control cable was also returned.The device was manually untangled and part of the embolic coil was seen advanced out of the distal end of the green introducer.There were no damages seen on the embolic coil.The resistive heating coil did not appear to receive heat or melt and the articulating junction between the embolic coil and dpu appeared intact with no damage.The extended coil section of the dpu past the marker band exhibited kinks and was twisted creating a small loop.The microcoil system was connected to the returned enpower control cable and the control cable was connected to the lab sample enpower dcb.The system ready light on the detachment control box did not illuminate.The coil could not be detached.The resistance of the microcoil system was tested and the multimeter was overloaded.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The complaint that the microcoil system could not be detached was confirmed.The enpower control cable passed functional testing and is not the cause of the failure to detach the coil.The most likely cause of the failure to detach is damage to the electrical wiring due to the kinks and twist on the distal end of the dpu.The damages to the dpu wire also reshaped and likely damaged the internal electrical wiring within the dpu.This can cause an increase in electrical resistance and a failure to deliver a charge to melt the detachment fiber.The circumstances that caused the damages are unknown; however, the device is 100% inspected in process during manufacturing for kinks and bends.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 event was related to a manufacturing issue, no corrective actions will be taken at this time.

• Brand Name: DELTAMAXX - CERECYTE MICROCOIL
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel ; SZ
• Manufacturer Contact: karen anigbo ; 821 fox lane; san jose, CA 95131 ; 5088288374
• MDR Report Key: 6613998
• MDR Text Key: 76737058
• Report Number: 2954740-2017-00116
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 10878528008597
• UDI-Public: (01)10878528008597(17)210430(10)S10592
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120274
• 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,Followup,Followup
• Report Date: 05/18/2017

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: 04/30/2021
• Device Catalogue Number: CDX18083530
• Device Lot Number: S10592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2017
• Initial Date FDA Received: 06/06/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 07/31/2017
• Supplement Dates FDA Received: 06/21/2017; 06/22/2017; 07/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1