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

Catalog Number CPL10015130

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

It is anticipated that the device will be returned for analysis; however, the device has not yet been returned.Additional information will be submitted within 30 days of receipt.

Event Description

As reported by a healthcare professional, a deltaplush coil (b)(4) failed to detach during the internal carotid artery procedure.The coil was removed from the patient still attached to the delivery system and was not stretched, and the procedure was continued using the same detachment control box and connecting cable.A pre-deployment electrical check had been performed.A fault light was not seen during the case.The system ready light illuminated and during detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.There were no potential adverse events or procedure delay.It was reported that the device would be returned for analysis.

Manufacturer Narrative

Conclusion: as reported by a healthcare professional, a deltaplush coil (cpl10015130 / c40124) failed to detach during the internal carotid artery procedure.The coil was removed from the patient still attached to the delivery system and was not stretched, and the procedure was continued using the same detachment control box and connecting cable.A pre-deployment electrical check had been performed.A fault light was not seen during the case.The system ready light illuminated and during detachment cycle, the detachment light illuminated and the audible signal beeped.All connections appeared to fit properly without application of excessive force.There were no potential adverse events or procedure delay.The device was returned for analysis.The device positioning unit (dpu) has been completely removed from the introducer.The embolic coil is detached from the dpu and is located in the translucent introducer sheath.There is a short, stretched segment of embolic coil attached to the dpu.There is a slight bend in the dpu core wire at approximately 64 cm from the proximal end.The ball tip is intact on the severed section of embolic coil.The distal end of the severed section of embolic coil is obscured by the translucent introducer sheath.The v-notch of the resheathing tool is undamaged.There is a stretched section of embolic coil attached to the dpu.The articulating joint is damaged.The resistance heating (rh) coil has not received heat and melted.The resistance of the device was measured and resistance was 53.9, which is within the specification range of 48.5 ¿ 56.The device was connected to a lab sample detachment control box dcb000005-00 (dcb) and with a standard connecting cable and the power was turned on.The system ready light illuminated.The remaining (attached to the dpu) section of embolic coil was immersed in warmed enzyme solution and a detach cycle was initiated.The remaining section of emboli coil detached from the dpu.Microscopic examination of the dpu shows that the embolic coil has detached.The rh coil is slightly darkened, indicating that it has received heat.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 was not confirmed.While a large section of embolic coil was severed, the remaining section detached under laboratory conditions.Without the return of the dcb and connecting cable used during the event, the cause of the reported failure to detach cannot be determined.The damage to the device (embolic coil severed, introducer removed) is inconsistent with the condition of the device after the event as reported in the complaint.The decontamination provider reported that the device was received in two pieces.The cause of this damage cannot be identified; however, based on information received, was related to post-procedure handling/shipping.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.

Manufacturer Narrative

The device was returned for analysis; however, the analysis has not yet been completed.Additional information will be submitted within 30 days of receipt.

• Brand Name: DELTAPLUSH - 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: 6848526
• MDR Text Key: 85138631
• Report Number: 2954740-2017-00253
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008163
• UDI-Public: (01)00878528008163(17)201231(10)C40124
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K083646
• 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
• Report Date: 08/18/2017

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: 12/31/2020
• Device Catalogue Number: CPL10015130
• Device Lot Number: C40124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 09/26/2017; 11/10/2017
• Supplement Dates FDA Received: 10/19/2017; 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1