MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 2MM X 2.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100202
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Procode: krd/hcg.The company is seeking this information through the event investigation.The product is not available for evaluation and testing.Additional information will be submitted within 30 days of receipt.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 a coil embolization, a 2mm x 2.5cm micrusframe10 coil (mfr100202, l16704) was being used as the first coil.When the physician tried to detach the coils, the beeping sound was normal but during retrieving delivery system, it continuously came out along the delivery systems.The physician used a same like product.The procedure was successfully finished.There was no report of patient injury.
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, a 2mm x 2.5cm micrusframe10 coil (mfr100202, l16704) was being used as the first coil.When the physician tried to detach the coils, the beeping sound was normal but during retrieving delivery system, it continuously came out along the delivery systems.The physician used a same like product.The procedure was successfully finished.There was no report of patient injury.One non-sterile micrusframe10 2mm x 2.5cm 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.Also, the marker band was found at 37cm from distal end and it was found within specification.The resistance of the device was measured with multimeter and a lab sample enpower control cable.Resistance initially measured approximately 52.5 o, which is in of the specification range.Also, the received unit micrusframe10 2mm x 2.5cm 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.A manufacturing record evaluation was performed for the finished device l16704 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 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 suggests 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 and damages on the returned system.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: MICRUSFRAME10 2MM X 2.5CM
• 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: 10074811
• Report Number: 3008114965-2020-00178
• Device Sequence Number: 2916212
• Product Code: KRD
• UDI-Device Identifier: 10886704077787
• UDI-Public: 10886704077787
• Combination Product (Y/N): N
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2020

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: 07/31/2022
• Device Model Number: MFR100202
• Device Catalogue Number: MFR100202
• Device Lot Number: L16704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1