MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 15MM X 50CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR181550
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
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.Initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.Component code: part/component/sub-assembly term not applicable was selected.The device was discarded, therefore, no further investigation can be performed.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the reported complaint condition were identified 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 coil embolization of an aneurysm at the splenic artery, a 15mm x 50cm micrusframe18 coil (mfr181550, k10194) was being used as a framing coil.The delivery wire was advanced but there was a resistance felt and it was not able to move.The physician attempted to remove the 15mm x 50cm micrusframe18 coil but it prematurely detached.However, the user was able to remove the coil from the patient.It was replaced with another 15mm x 50cm micrusframe18 coil (mfr181550, l16935) but there was also a resistance felt.It was attempted to be re-sheathed but the sheath got damaged.It was replaced with another coil and framing was done.Another smaller presidio coil, competitive coils and two deltafill18 coils were implanted.The procedure was completed.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.Section b5: additional information was received indicating that the resistance was felt during advancement.No excessive force was applied to the device.No further information is available.Complaint conclusion: as reported by the field, during a coil embolization of an aneurysm at the splenic artery, a 15mm x 50cm micrusframe18 coil (mfr181550, k10194) was being used as a framing coil.The delivery wire was advanced but there was a resistance felt and it was not able to move.The physician attempted to remove the 15mm x 50cm micrusframe18 coil but it prematurely detached.However, the user was able to remove the coil from the patient.It was replaced with another 15mm x 50cm micrusframe18 coil (mfr181550, l16935) but there was also a resistance felt.It was attempted to be re-sheathed but the sheath got damaged.It was replaced with another coil and framing was done.Another smaller presidio coil, competitive coils and two deltafill18 coils were implanted.The procedure was completed.There was no report of patient injury.Additional information was received indicating that the resistance was felt during advancement.No excessive force was applied to the device.No further information is available.The 15mm x 50cm micrusframe18 coil was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device k10194 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ and ¿coil - premature detachment-in mc during removal¿ could not be confirmed.Based on the device history record review, there is no indication that the events are related to the device manufacturing process.The instructions for use (ifu) warns that if the microcoil system becomes immobile in the infusion microcatheter, apply a gentle push-pull motion to free it.If unsuccessful, remove both microcatheter and microcoil system together as a unit and replace with new devices.The ifu cautions the operator to never advance, withdraw, or torque the delivery tube against resistance without first determining the cause of resistance under fluoroscopy.Manipulation of the delivery tube against resistance can cause damage and/or premature detachment of the coil.Assignment of root cause for the events remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction, aneurysm size and vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issues.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 suggests the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MICRUSFRAME18 15MM X 50CM
• 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: 10929461
• Report Number: 3008114965-2020-00547
• Device Sequence Number: 545924
• Product Code: KRD
• UDI-Device Identifier: 10886704078128
• UDI-Public: 10886704078128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: 10/31/2022
• Device Model Number: MFR181550
• Device Catalogue Number: MFR181550
• Device Lot Number: K10194
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/20/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/11/2021
• 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: MICRUSFRAME18 15MM X 50CM