MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 4MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR140406
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The embolic coil was noted to being kinked, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Manufacturing site name: (b)(4).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.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2019-01168, and 3008114965-2019-01167.Complaint conclusion: as reported by a healthcare professional, the tab to unlock a 4mm x 6cm micrusframe14 coil (mfr140406,s13486) broke.A hemostat was used to manually pull the tab from the green unlocking tool.The coil was not used in case because of that reason.There was no patient injury as the device was not clinically used.No further information is available.One non-sterile unit micrusframe14 4mm x 6cm 4cm was received inside of a pouch.The hub was inspected and no damages was noted on it.The dpu was inspected and it was found protruded from the introducer, but no damages was noted on it.The introducer was inspected, and it was found partially unzipped and damaged.The re-sheathing tool was inspected and it was found with no damages on it.Also, the marker band was found at 41cm from hub, and it was found within specification.The v-notch was inspected under microscope and it was found cracked.The rh was inspected under microscope and it was found in good condition.The embolic coil was inspected under microscope an it was found kinked.A manufacturing record evaluation was performed for the finished device s13486 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil introducer - damaged¿ was confirm during the visual analysis due the introducer was found damaged.The condition noted on the introducer appears 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 suggest that the failure reported by the costumer could be related to the manufacturing process.Based on the limited information provided, it is possible that the storing or handling of the device may have contributed to the reported issue.The instructions for use recommends to visually examine the microcoil for any anomalies such as kinks, burrs, stretched coil, striations, or other damages.If any anomalies are noted or if there is difficulty advancing the microcoil from the introducer sheath, the unit may be defective.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.
Event or Problem Description
As reported by a healthcare professional, the tab to unlock a 4mm x 6cm micrusframe14 coil (mfr140406, s13486) broke.A hemostat was used to manually pull the tab from the green unlocking tool.The coil was not used in case because of that reason.There was no patient injury as the device was not clinically used.No further information is available.Based on the findings of the device investigation, the embolic coil was noted to being kinked.

• Brand Name: MICRUSFRAME14 4MM X 6CM
• 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: 9146292
• Report Number: 3008114965-2019-01188
• Device Sequence Number: 2700485
• Product Code: KRD
• UDI-Device Identifier: 10886704077978
• UDI-Public: 10886704077978
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2019

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: 02/29/2020
• Device Catalogue Number: MFR140406
• Device Lot Number: S13486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1