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	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by the field, during an auxiliary aneurysm embolization, a 1.5mmx6cm deltapaq cere coil (cdf10015630, s13582) couldn¿t be released when it arrived the cerebral target position.The physician withdrew it, and used another new coil to complete the procedure.There was no patient harm reported.Additional information received indicated that pre-deployment electrical testing was performed.The same detachable control box (dcb), and the control cable were used successfully with subsequent coils.The coil was still attached to the coil delivery system when it was removed from the patient.The coil was not stretched, or damaged when it was removed from the patient.No excessive force was applied to the device.It was not necessary to remove concomitant devices with the complaint device.Adequate flush was maintained through the devices.The event prolonged the procedure by a few minutes.The physician did not feel the prolongation of procedure was clinically significant.
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 auxiliary aneurysm embolization, a 1.5mmx6cm deltapaq cere coil (cdf10015630, s13582) couldn¿t be released when it arrived at the cerebral target position.The physician withdrew it and used another new coil to complete the procedure.There was no patient harm reported.Additional information received indicated that pre-deployment electrical testing was performed.The same detachable control box (dcb) and the control cable were used successfully with subsequent coils.The coil was still attached to the coil delivery system when it was removed from the patient.The coil was not stretched or damaged when it was removed from the patient.No excessive force was applied to the device.It was not necessary to remove concomitant devices with the compliant device.Adequate flush was maintained through the devices.The event prolonged the procedure by a few minutes.The physician did not feel the prolongation of the procedure was clinically significant.A non-sterile unit deltapaq cere 1.5mmx6cm was received inside of a pouch.The device was visually inspected, and it was found in good normal conditions, no anomalies or damages were observed during the visual inspection.The device was inspected under a microscope and the embolic coil was found with a kinked condition, also, it was stuck inside the introducer.The functional test could not be performed due to the stuck condition noted on the embolic coil.A manufacturing record evaluation was performed for the finished device s13582 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - failure to detach¿ could not be evaluated, since during the analysis it was noted that the embolic coil has a kinked condition, also it was stuck inside the introducer.Due to these conditions, the functional test could not be performed.This condition could be contributing to the complaint reported by the customer since the embolic coil needs to be out of the introducer to start the detachment cycle.Based on the information obtained during the analysis the customer complaint was confirmed.The kinked condition noted on the embolic coil might appear to have been caused by excessive force and handling being applied to the device however none of those can be conclusively determined.Neither the analysis nor the mre suggests that the failure reported by the customer 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.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: 10568052
• Report Number: 3008114965-2020-00422
• Device Sequence Number: 2704699
• 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): 09/02/2020

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: 02/28/2022
• Device Model Number: CDF100156-30
• Device Catalogue Number: CDF10015630
• Device Lot Number: S13582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1