MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPAQ CERE 2MMX10CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10021030

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity were not provided.(b)(4).The initial reporter contact information is unknown.(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

A report was received that the 2mm x 10cm deltapaq thermo-mechanical coil (cdf10021030/c37635) failed to detach during the procedure.Another coil was used to complete the procedure.There was no report of consequence or impact to the patient.The product will be returned for analysis.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Additional information received indicated that the coil delivery system was successfully removed from the patient; however, it is not known if the coil was stretched when removed.The coil was still attached to the delivery system.An enpower detachment control box (dcb) and enpower control cable were used for the case.The same dcb and control cable were utilized to detach subsequent coils.A pre-deployment electrical check was performed.A ¿low battery¿ light was not visualized during the procedure.It is not known if a ¿fault¿ light was seen during the case.The green ¿system ready¿ light illuminated.All connections appeared to fit properly without application of excessive force.The event did not result in a procedural delay.The intended procedure was a coil embolization of an intracranial aneurysm.The concomitant products used are not available for return.Procode: krd/hcg.Concomitant med products due to character limitation: enpower detachment control box (dcb), enpower control cable.(b)(6).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an intracranial aneurysm, the 2mm x 10cm deltapaq thermo-mechanical coil (cdf10021030/c37635) failed to detach.The coil was successfully removed from the patient and replaced to complete the procedure.The coil was still attached to the delivery system upon removal.It is not known if the coil was stretched when removed.The event did not result in a procedural delay.There was no report of consequence or impact to the patient.An enpower detachment control box (dcb) and enpower control cable were used for the case.The same dcb and control cable were utilized to detach subsequent coils.A pre-deployment electrical check was performed.A ¿low battery¿ light was not visualized during the procedure.It is not known if a ¿fault¿ light was seen during the case.The green ¿system ready¿ light illuminated.All connections appeared to fit properly without application of excessive force.No further information was provided.The device was returned with its inner pouch.Labeling on the inner pouch matched the product documented in the complaint.The returned device was tightly coiled.The device was carefully uncoiled.The embolic coil was located in the translucent introducer sheath.The tip coil section of the device positioning unit (dpu) passed through the resheathing tool.On the distal side of the resheathing tool, approximately 4 mm of the tip coil is protruded from the skive of the translucent introducer sheath.There was a bend in the dpu core wire approximately 109 cm from the proximal end.The ball tip was intact.The embolic coil was kinked.The condition of the articulating joint and resistance heating (rh) coil was obscured by the translucent introducer sheath.On the distal side of the resheathing tool the distal end of the dpu protruded from the skive of the translucent introducer sheath.The protruded section passed into the resheathing tool.The v-notch of the resheathing tool was undamaged.An attempt was made to advance the embolic coil out of the introducer to visualize the articulating joint and rh coil.Because of the protruded section of dpu, the embolic coil could not be advanced.An attempt was made to retract the coil through the resheathing tool to visualize the articulating joint and rh coil.The embolic coil could not be retracted through the resheating tool without applying excessive force, which could damage the embolic coil or articulating joint.Resistance of the device was measured and found within specification range.The device was connected to lab detachment control box dcb000005-00 (dcb) f79684 with lab enpower control cable c10702 and the power was turned on.The system ready light illuminated.Detachment could not be tested because the embolic coil could not be removed from the introducer.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 could not be confirmed.Protrusion of the dpu through the skive of the translucent introducer sheath prevented advancement of the embolic coil out of the introducer.Therefore, detachment could not be directly tested and the condition of the rh coil could not be visualized.Resistance of the device tested within specification, and the system ready light illuminated when the device was connected to a lab dcb.The enpower dcb and connecting cable used in the event were not returned.Without the return of these devices, the cause of the reported event cannot be determined.The protrusion of the distal end of the dpu from the skive of the translucent introducer sheath prevented testing of detachment.In the returned device, the resheathing tool has been advanced over the tip coil of the dpu 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 and the more flexible and fragile distal sections of the dpu inside the microcatheter before continuing to unsheathe the device.If the device is unsheathed before advancing into the microcatheter, there is a risk that the embolic coil or the distal end of the dpu will be unsheathed and pass through the resheathing tool.If the resheathing tool passes over the distal end of the dpu, this will expose these flexible sections, which will then be subject to kinking and bending.Once a part of the dpu is kinked or bent, the translucent introducer sheath will not be able to re-form around it, and that section of the device will protrude.In addition, the embolic coil of the returned device was kinked.The cause of the kink could not be determined from the condition of the returned device.However, 100% of devices are tested in-process by advancing the embolic coil out of the introducer and retracting it back in.A kink in the embolic coil would prevent advancement of the device, and would be rejected at this step.Thus, it is unlikely that the device left the manufacturing facility with the observed damage to the embolic coil.Neither the product analysis nor the manufacturing review suggest that the failure could be related to the device manufacturing process.The exact cause of the event could not be conclusively determined; however, it is possible that circumstances of the procedure may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective/preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: DELTAPAQ CERE 2MMX10CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7244275
• MDR Text Key: 99788496
• Report Number: 3008114965-2018-00521
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007111
• UDI-Public: 00878528007111
• Combination Product (y/n): N
• PMA/PMN Number: K080437
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/10/2018

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: 07/31/2020
• Device Catalogue Number: CDF10021030
• Device Lot Number: C37635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2018
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 03/01/2018
• Supplement Dates FDA Received: 03/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1