MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 7MM X 17CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR140717
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr is to include the additional event information received on 21-nov-2019.The additional event information resulted in a change in the reportability of this complaint.This complaint does not meet the criteria for medical device reporting since the issue occurred during pre-deployment electrical testing and the coil was successfully implanted in the patient.Therefore, it has been deemed not reportable.No further reports will be forthcoming.Additional information received indicated that the issue occurred during pre-deployment electrical testing.The same dcb and cable were used successfully with subsequent coils.The 7mm x 17cm micrusframe14 coil was finally implanted.
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.(b)(4).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.Based on picture provided, dpu and connector looks with no damage, and coil can be observed still attached to device.However, the reported condition cannot be confirmed until the device is returned.Further investigation will be performed if the device is received for analysis.A manufacturing record evaluation was performed for the finished device l12061 number, and no non-conformances related to the reported complaint condition were identified.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 a healthcare professional, during a coil embolization, a 7mm x 17cm micrusframe14 coil (mfr140717, l12061) was being used as a third coil, however, tried it several times, but it was not ¿detailed¿.There was no patient injury reported.A picture of the device was received.

• Brand Name: MICRUSFRAME14 7MM X 17CM
• 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: 9304935
• Report Number: 3008114965-2019-01238
• Device Sequence Number: 2195772
• Product Code: KRD
• UDI-Device Identifier: 10886704078012
• UDI-Public: 10886704078012
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 03/31/2021
• Device Catalogue Number: MFR140717
• Device Lot Number: L12061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1