MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 12MM X 40CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR181240
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
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.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.
Event or Problem Description
As reported by the field, during a coiling embolization of an of an aneurysm (basilar top), a 12mm x 40cm micrusframe coil (mfr181240, l13777) did not want to detach, even after 8 attempts.When trying to pull back the coil into the sl10 microcatheter (after 2cm), it finally did detach.The physician was able to put it back into the aneurysm.The detachment box functioned well for the rest of the coil detachments in the procedure.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 a coiling embolization of an of an aneurysm (basilar top), a 12mm x 40cm micrusframe coil (mfr181240, l13777) did not want to detach, even after 8 attempts.When trying to pull back the coil into the sl10 microcatheter (after 2cm), it finally did detach.The physician was able to put it back into the aneurysm.The detachment box functioned well for the rest of the coil detachments in the procedure.There was no patient injury reported.No additional information is available.One non-sterile micrusframe18 12mm x 40cm 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 been softened indicating that the resistance heating coil had been heated and the detachment process was initiated.The embolic coil was not received for evaluation.No other damages were observed.The marker band was found at 75cm from hub, which is within specification.A manufacturing record evaluation was performed for the finished device l13777 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 due the device was found already heated.The root cause why the device could not be separated on the first attempt remains unknown as no damage to the device was found that could have contributed to the reported complaint.The complaint reported by the customer ¿coil - premature detachment-in mc during removal" was confirmed since the embolic coil was found detached from the unit, however the exact time when this condition occur remains unknown.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 and damages on the returned system.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: MICRUSFRAME18 12MM X 40CM
• 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: 10183542
• Report Number: 3008114965-2020-00253
• Device Sequence Number: 19054104
• Product Code: KRD
• UDI-Device Identifier: 10886704078098
• UDI-Public: 10886704078098
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 08/31/2021
• Device Model Number: MFR181240
• Device Catalogue Number: MFR181240
• Device Lot Number: L13777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/11/2020
• 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: SL-10® MICROCATHETER (STRYKER)