MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAPAQ CERE 1.5MMX6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CDF100156-30
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Procode: krd/hcg.(b)(6).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 device is available to be returned for evaluation and testing.However, it has not been received to date.If the device returns, a device investigation will be performed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2020-00208.
Event or Problem Description
As reported by the field, during an aneurysm embolization, a 1.5mmx6cm deltapaq cere coil (cdf10015630, s13690) couldn't be detached.The physician replaced the device for a 1.5mmx6cm deltapaq cere (cdf10015630, s14698) but it failed to detach too.Then the physician changed the device and the third was able to finally detach successfully.There was no patient injury reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by the field, during an aneurysm embolization, a 1.5mmx6cm deltapaq cere coil (cdf10015630, s13690) couldn't be detached.The physician replaced the device for a 1.5mmx6cm deltapaq cere (cdf10015630, s14698) but it failed to detach too.Then the physician changed the device and the third was able to finally detach successfully.There was no patient injury reported.One non-sterile deltapaq cere 1.5mmx6cm unit was received inside of a pouch.The received device was visually inspected, and no damages were noted on it.Then a microscopic inspection was performed, and the distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated.No other damages were observed.The resistance of the device was measured with multimeter and a lab sample enpower control cable.Resistance initially measured approximately 54.9 o, which is in of the specification range.Also, the received unit deltapaq cere 1.5mmx6cm was connected to a lab sample enpower control cable and they were connected to detachment control box (dcb) and the power was turned on.The system ready light illuminated.A detachment cycle was initiated when the detach button was pressed.After that, the embolic coil was detached from the device.The complaint reported by the customer ¿coil - failure to detach¿ could not be confirmed because the device was found within the specifications in the functional test.After that the embolic coil was detached from the device.Neither the analysis nor the mre suggest that the failure reported could be related to the manufacturing process.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.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure.Based on microscopic inspection, the distal outer sheath had not been softened indicating that the resistance heating coil had not been heated and the detachment process was not initiated.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.

• Brand Name: DELTAPAQ CERE 1.5MMX6CM
• 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: 10092399
• Report Number: 3008114965-2020-00207
• Device Sequence Number: 16924664
• Product Code: HCG
• UDI-Device Identifier: 00878528007043
• UDI-Public: 00878528007043
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K080437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2020

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: 03/31/2022
• Device Model Number: CDF100156-30
• Device Catalogue Number: CDF10015630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/28/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELTAPAQ CERE 1.5MMX6CM.
• Patient Age: 32 YR