MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL10 6MM X 16CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF100616
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.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.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 3008114965-2020-00297.
Event or Problem Description
As reported by the field, during a coil embolization, two deltafill coils (dlf100616, l11401 and dlf100820, l11765) didn¿t detach properly.There was no patient injury reported.No other information was provided at the time of report.
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 a coil embolization, two deltafill coils (b)(6) didn¿t detach properly.There was no patient injury reported.No other information is available.The device was not returned; therefore, no product investigation can be performed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil ¿ failure to detach¿ could not be confirmed.Based on the device history record review, there is no indication that the event is related to the device 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 without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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: DELTAFILL10 6MM X 16CM
• 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: 10327197
• Report Number: 3008114965-2020-00296
• Device Sequence Number: 16866316
• Product Code: KRD
• UDI-Device Identifier: 10886704077107
• UDI-Public: 10886704077107
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2020

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: 01/31/2021
• Device Model Number: DLF100616
• Device Catalogue Number: DLF100616
• Device Lot Number: L11401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 07/27/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: UNK COIL-THERMO MECHANICAL