MAUDE Adverse Event Report: REFER TO SECTION H10 DELTAPL CERE COIL 10 SYS 1.5X3; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number CPL100153-30

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information regarding patient age, gender, weight, medical history, race, and ethnicity were not provided.(b)(4).(b)(6).(b)(4).The product has not been returned for evaluation and testing.Additional information will be submitted within 30 days upon receipt.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.

Event Description

As reported by a healthcare professional, during a coil embolization of an aneurysm, the 1.5mm x 3cm deltaplush thermo-mechanical coil (b)(4) could not be detached despite multiple attempts, manipulation, and exchange of control cables and detachment control systems.The coil was subsequently removed from the patient and replaced.The issue resulted in ¿ineffective manipulation¿ in the aneurysm.There was no reported consequence or impact to the patient.The device had not been reprocessed and reused on a patient.The user was trained.The device will be returned for analysis.No further information was provided.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an aneurysm, the 1.5mm x 3cm deltaplush thermo-mechanical coil (cpl10015330/s11803) could not be detached despite multiple attempts, manipulation, and exchange of control cables and detachment control systems.The coil was subsequently removed from the patient and replaced.The issue resulted in ¿ineffective manipulation¿ in the aneurysm.There was no reported consequence or impact to the patient.The device had not been reprocessed and reused on a patient.The user was trained.No further information was provided.Multiple attempts to obtain additional information were unsuccessful.The device was returned with its inner pouch.Labeling on the inner pouch matched the product documented in the complaint.The device was completely unsheathed.The resheathing tool has been advanced all the way to the green introducer.There were bends in the device positioning unit (dpu) core wire at the strain relief and approximately 16 cm, 46 cm, 55 cm, 64 cm, 65 cm, 71 cm, 127 cm, 128 cm, 129 cm, 132 cm, and 147 cm from the proximal end, and a kink approximately 138 cm from the proximal end.There was blood on the embolic coil.The ball tip was intact.The embolic coil was kinked.The articulating joint was damaged.The resistance heating (rh) coil had not heated.The marker band was bent.The v-notch of the resheathing tool was undamaged.The resistance of the device was measured and found within specification.The device was connected to lab detachment control box (b)(4) (dcb) f79684 with lab enpower control cable c10702 and the power was turned on.The system ready light illuminated.The embolic coil was immersed in warmed enzyme solution and the detach button was pressed.The embolic coil detached.After detachment, microscopic examination showed that the rh coil had heated.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.The embolic coil successfully detached under lab conditions.Prior to lab detachment, the rh coil had not heated, and following detachment, the rh coil had heated.The bends and kink observed in the dpu core wire and marker band, as well as the kinked embolic coil, are evidence of the application of excessive force to the device.The exact circumstances surrounding the event are unknown, and the reason for the application of excessive force is not apparent upon evaluation of the returned device.100% of devices are inspected for damage to the dpu, including kinks, at quality control (qc) final inspection.In addition, 100% of devices are inspected in-process by advancing the embolic coil out of the introducer and retracting it back in.Damage to the embolic coil or articulating joint would prevent the embolic coil from advancing out of the introducer, and would be identified in this inspection.Thus, it is very unlikely that the device left the manufacturing facility with the observed damage.The exact cause of the event could not be conclusively determined; however, there are circumstances of the procedure that may have contributed to the reported failure.Neither the manufacturing review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.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: DELTAPL CERE COIL 10 SYS 1.5X3
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO SECTION H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7182289
• MDR Text Key: 97736277
• Report Number: 2954740-2018-00501
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528008194
• UDI-Public: (01)00878528008194(17)210930(10)S11803
• Combination Product (y/n): N
• PMA/PMN Number: K083646
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: CPL100153-30
• Device Catalogue Number: CPL10015330
• Device Lot Number: S11803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Date Manufacturer Received: 02/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1