MAUDE Adverse Event Report: SEE H.10 DELTAPAQ CERE 2MMX2CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number CDF10020230

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.(b)(4).Initial reporter information such as the name, phone and email address are unknown.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.The device has not been returned.If the device returns, a device investigation will be performed.Additional information will be submitted within 30 days of receipt.

Event Description

The healthcare professional reported that during the coil embolization procedure, the deltapaq 10 cerecyte coil 2 mm x 2 cm (cdf10020230 / c34616) could not be detached.The coil was withdrawn and replaced; another coil was used to complete the procedure.There was no report of patient injury or adverse event.It was indicated that the deltapaq cerecyte coil is available to be returned for analysis.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).[conclusion]: the healthcare professional reported that during the coil embolization procedure for an intracranial aneurysm, the deltapaq 10 cerecyte coil 2mm x 2cm (catalog #: cdf10020230 / lot #: c34616) could not be detached; it was used with the enpower detachment control box and enpower connecting cable.The coil was successfully removed from the patient still attached to the delivery system and replaced; another coil was used to complete the procedure using the same detachment control box and the same connecting cable.It was confirmed that a pre-deployment electrical check was performed on the detachment control box.The low battery light was not seen, and the system ready light illuminated.All the connections were properly fitted without the application of excessive force.There was no report of patient injury or adverse event, there was also no clinical delay related to the reported issue.The deltapaq cerecyte coil is available to be returned for analysis.The investigational finding is documented below.Investigation summary: the device was returned with the embolic coil inside the introducer.The device was also returned significantly unsheathed as indicated by the length of the introducer proximal to the re-sheathing tool.The device positioning unit (dpu) core wire was seen protruding from the skive of the translucent introducer.The dpu core wire was kinked at the strain relief valve and at approximately 7 cm and 27 cm from the proximal end of the device.The embolic coil ball tip was seen in the green section of the introducer.The articulating joint was seen in the translucent introducer.The dpu core wire was seen protruding from the skive of the introducer.The dpu core wire was seen entering the distal end of the re-sheathing tool outside the introducer.The v-notch of the re-sheathing tool was seen undamaged.The device was advanced, and the embolic coil and articulating joint were moved outside the introducer.There is contrast solution seen within the distal outer sheath.The embolic coil distal ball tip was present and intact.The device was connected to the lab multimeter and the resistance was measured, however the multimeter gave a reading of open loop.The device was then connected to an enpower detachment control box dcb000005-00 (dcb) c38341 and enpower control cable c10702.The dcb was powered on, however the system ready light did not illuminate.The detachment process could not be initiated.A review of manufacturing documentation associated with this lot (c34616) presented no issues during the manufacturing or inspection processes related to the reported complaint.All product rejected during manufacturing was identified as scrap and properly accounted for.Investigation conclusion: the complaint of coil failure to detach is confirmed.Detachment was unable to be performed as the dcb device was not able to detect the device connection.The multimeter indicated that there was an open loop in the device.It is possible that the kinks found in the dpu core wire caused the open loop to occur.Kinks in the dpu core wire are likely a result of user handling and excessive force.The ifu states to carefully remove the device from the loading hoop and gives instructions during use to align the core wire with the opening hubs of the rotating hemostat (rh)valves when inserting the device.Devices undergo 100% inspection for kinks to the dpu core wires as well as tested to ensure resistance specification is met.The distal outer sheath and detachment zone area is inspected.It is unlikely that the device left the manufacturing facility with the observed failure.With the information provided in the complaint and the investigation findings documented, the reported issue that the deltapaq 10 cerecyte coil 2mm x 2cm failed to detach during the procedure was confirmed.The returned device was not able to establish a connection to the detachment control box and had an open loop when it was connected to the lab multimeter.The likely cause of the open loop detected could be due to the kinks found in the dpu core wire.The likely cause of the observed kinks in the dpu core wire is handling and applied excessive force.Based on the device history record review, there is no indication that the event is 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 and/or device manipulation/interaction may have contributed to the reported failure.Devices undergo 100% inspection at final assembly thus, it is not likely that the deltapaq 10 cerecyte coil 2mm x 2cm left the manufacturing facility with the kinks observed in the dpu core wire.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.Additional information will be submitted within 30 days of receipt.

• Brand Name: DELTAPAQ CERE 2MMX2CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): SEE H.10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7851844
• MDR Text Key: 119934717
• Report Number: 3008114965-2018-00715
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528007067
• UDI-Public: 00878528007067
• 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: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: CDF10020230
• Device Lot Number: C34616
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1