MAUDE Adverse Event Report: REFER TO H10 CASH 14 CERE 2MMX2.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number CRC140225-30

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).Information regarding patient age, gender, weight, race, ethnicity, and medical history were not provided.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 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 intracranial aneurysm, a 2 mm x 2.5 cm cashmere thermo-mechanical microcroil (crc14022530/c29515) could not be detached.The coil was successfully removed from the patient and another coil was used to complete the case.The same enpower detachment control box and connecting cable were used to detach subsequent coils.The coil was still attached to the delivery system when removed from the patient and the coil was not stretched when it was removed.There was no report of patient injury.A pre-deployment electrical check was performed.The green system ready light illuminated.Neither a low battery light nor a fault light were visualized during the case.All connections appeared to fit properly without application of excessive force.It is unknown if all lights illuminated when the power button was pressed.It is also unknown if the detachment light illuminated and the audible signal beeped during the detachment cycle.The product will be returned for analysis.No further information was provided.

Manufacturer Narrative

Product complaint # (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.

Manufacturer Narrative

Product complaint # (b)(4).Complaint conclusion: as reported by a healthcare professional, during a coil embolization of an intracranial aneurysm, a 2 mm x 2.5 cm cashmere thermo-mechanical microcroil (crc14022530/c29515) could not be detached.The coil was successfully removed from the patient and another coil was used to complete the case.The same enpower detachment control box and connecting cable were utilized to detach subsequent coils.The coil was still attached to the delivery system when removed from the patient and the coil was not stretched when it was removed.There was no patient injury reported.A pre-deployment electrical check was performed.The green system ready light illuminated.Neither a low battery light nor a fault light were visualized during the case.All connections appeared to fit properly without application of excessive force.It is unknown if all lights illuminated when the power button was pressed.It is also unknown if the detachment light illuminated and the audible signal beeped during the detachment cycle.The device was returned with its inner pouch.Labeling on the inner pouch matched the product documented in the complaint.The embolic coil was located in the green introducer.There were bends in the device positioning unit (dpu) core wire at the strain relief and approximately 3 cm from the strain relief.The ball tip was intact.There were no kinks or stretched sections in the embolic coil.The condition of the articulating joint and resistance heating (rh) coil were obscured by the green introducer.There was a slight amount of plastic remodeling damage to the v-notch of the resheathing tool.The embolic coil was advanced out of the introducer to visualize the articulating joint and rh coil.The articulating joint is intact.The rh coil had not been heated.Resistance of the device was measured and found within the specification range.The device was connected to lab detachment control box dcb000005-00 (dcb) with lab enpower connecting cable and the power was turned on.The system ready light illuminated.The embolic coil was submerged in warmed enzyme solution and the detach button was pressed.The embolic coil detached.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 of failure to detach was not confirmed.The embolic coil detached under lab conditions and using a lab enpower connecting cable and lab dcb.Microscopic examination demonstrated that the rh coil had not heated prior to the lab detachment attempt and had heated after the lab detachment attempt.With review of the reported information and analysis of the returned device, and without return of the associated dcb and connecting cable, a definitive conclusion regarding the root cause of the reported event cannot be determined.However, there are circumstances of the procedure that 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: CASH 14 CERE 2MMX2.5CM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): REFER TO H10; 47709 fremont blvd; fremont CA 94538
• MDR Report Key: 7144055
• MDR Text Key: 95792075
• Report Number: 3008114965-2017-00512
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00878528004400
• UDI-Public: (01)00878528004400(17)190831(10)C29515
• Combination Product (y/n): N
• PMA/PMN Number: K072173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: CRC140225-30
• Device Catalogue Number: CRC14022530
• Device Lot Number: C29515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Date Manufacturer Received: 02/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1