MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 3MM X 6CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR140306
Medical Device Problem Codes	Unraveled Material (1664); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.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.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 an intracerebral coil embolization of the posterior cerebral artery right (bifurcation 6x4.5mm aneurysm), when using a 3mm x 6cm micrusframe14 coil (mfr140306, l16488) as the second coil, the coil protruded into the vessel and the preshaped prowler14 45tip microcatheter (606151fx, 30148965) was dislocated.The coil was resheathed but became stretched inside the coil sheath.The microcatheter was removed together with the coil.The prowler14 was removed because it was not possible to completely resheath the micrusframe14.The coil was discarded and the prowler 14 microcatheter was checked and regarded as okay, no issues.The microcatheter (mc) was used for the remaining of the procedure with two additional coils.There was no report of patient injury.There was no resistance/friction between the coil and the mc prior to the stretching.Prior to this coil, other coils had been advanced through the same microcatheter.The coil of the micrusframe14 was still attached to the delivery wire when removed from the patient.The device did not prematurely detach.There was no excessive force applied to the devices.The device was removed from the patient without additional intervention.Adequate flush been maintained through the devices.
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 an intracerebral coil embolization of the posterior cerebral artery right (bifurcation 6x4.5mm aneurysm), when using a 3mm x 6cm micrusframe14 coil (mfr140306, l16488) as the second coil, the coil protruded into the vessel and the preshaped prowler14 45tip microcatheter (606151fx, 30148965) was dislocated.The coil was resheathed but became stretched inside the coil sheath.The microcatheter was removed together with the coil.The prowler14 was removed because it was not possible to completely resheath the micrusframe14.The coil was discarded and the prowler 14 microcatheter was checked and regarded as okay, no issues.The microcatheter (mc) was used for the remaining of the procedure with two additional coils.There was no report of patient injury.There was no resistance/friction between the coil and the mc prior to the stretching.Prior to this coil, other coils had been advanced through the same microcatheter.The coil of the micrusframe14 was still attached to the delivery wire when removed from the patient.The device did not prematurely detach.There was no excessive force applied to the devices.The device was removed from the patient without additional intervention.Adequate flush been maintained through the devices.One non-sterile micrusframe14 3mm x 6cm was received inside of a pouch.The device was visually inspected and the dpu was found with several kinks and protruded from the introducer.Then a microscopic inspection was performed, the embolic coil was found kinked, stretched and protruded from the introducer, no other damages could be observed.The marker band was found at 41cm from distal end and it was found within specification.A manufacturing record evaluation was performed for the finished device l16488 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil ¿ positioning difficulty-coil herniation ¿could not be evaluated because it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab, however the embolic coil was found stretched and kinked, these conditions may have been contributed to the difficulty of positioning the coil reported by the customer and due to this we can confirm the complaint.The complaint reported by the customer ¿coil ¿ unraveled/stretched¿ was confirmed since the embolic coil was found stretched and kinked on the microscopic inspection.The damaged condition noted on the device may have appeared 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 or the mre suggest that the failure reported could be related to the manufacturing process.The instructions for use (ifu) instructs on proper positioning of the microcoil system.The ifu also warns: ¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system¿.Assignment of root cause for the events 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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MICRUSFRAME14 3MM 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: 10338095
• Report Number: 3008114965-2020-00309
• Device Sequence Number: 3484280
• Product Code: KRD
• UDI-Device Identifier: 10886704077961
• UDI-Public: 10886704077961
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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: MFR140306
• Device Catalogue Number: MFR140306
• Device Lot Number: L16488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 08/24/2020
• 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: PRESHAPED PROWLER14 45TIP 2MRK.
• Patient Age: 54 YR