MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HELI 18 CERE, 2MMX4CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CHE180204-30
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient identifier, date of birth, weight, race, ethnicity, and medical history were not provided.Procode is krd/hcg.Physical manufacturer name: codman and shurtleff inc., dba depuy synthes products, inc.((b)(4)).[conclusion]: the healthcare professional reported that during the procedure, the 2mm x 4cm helipaq 18 cerecyte coil (che18020430 / l12647) did not detach.The coil was successfully removed from the patient still attached to the delivery system.The coil was not stretched when it was removed.It was reported that a pre-deployment electrical check was performed.The low battery light and the fault light were not seen during the case.The green system ready light illuminated when the power button was pressed; the audible signal beep was heard when the detachment cycle was initiated.All the connections were reported to fit properly without application of excessive force.A new cable was replaced before another coil was replaced but the 2mm x 4cm helipaq 18 cerecyte coil still would not detach.Another coil was used, and everything went well.The control cable and the detachment control box was used to detach subsequent coils.The reported issue did not result in any significant procedural delay.There was no report of any patient adverse event or complication.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (l12647) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Failure to detach is a known potential issue associated with the use of this device.The instructions for use (ifu) contains several precautions related to this issue and includes instructions for troubleshooting the situation should it be encountered during use.With the information provided in the complaint and without the product available for analysis, the reported issue by the customer cannot be confirmed.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue of the coil not being able to be detached during the procedure.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.This is one of two products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2020-00007.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.
Event or Problem Description
The healthcare professional reported that during the procedure, the 2mm x 4cm helipaq 18 cerecyte coil (che18020430 / l12647) did not detach.The coil was successfully removed from the patient still attached to the delivery system.The coil was not stretched when it was removed.It was reported that a pre-deployment electrical check was performed.The low battery light and the fault light were not seen during the case.The green system ready light illuminated when the power button was pressed; the audible signal beep was heard when the detachment cycle was initiated.All the connections were reported to fit properly without application of excessive force.A new cable was replaced before another coil was replaced but the 2mm x 4cm helipaq 18 cerecyte coil still would not detach.Another coil was used, and everything went well.The control cable and the detachment control box was used to detach subsequent coils.The reported issue did not result in any significant procedural delay.There was no report of any patient adverse event or complication.

• Brand Name: HELI 18 CERE, 2MMX4CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 9638487
• Report Number: 3008114965-2020-00008
• Device Sequence Number: 14174166
• Product Code: HCG
• UDI-Device Identifier: 00878528000709
• UDI-Public: 00878528000709
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K022420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: CHE180204-30
• Device Catalogue Number: CHE18020430
• Device Lot Number: L12647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1