MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME18 8MM X 30CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR180830
Medical Device Problem Codes	Difficult to Advance (2920); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a coil embolization for a renal artery aneurysm, a logos balloon catheter and an unspecified coiling support microcatheter (mc) were used.The complaint coil, a 8mmx30cm micrusframe coil (mfr180830, 30393168) was used as first coil.It was inserted into the microcatheter as it was pressed against the hub of the microcatheter, but there was a resistance felt before it came out inside blood vessel.It was re-sheathed but the coil part got prematurely detached in a concomitant microcatheter.The microcatheter was replaced with another one (coiling support) and a micrusframe coil (mfrs180830, unknown lot) was used as second coil without any problems.After that, the procedure completed with another different sized targetxl coil(s).There was no patient injury reported.A continuous flush was done.Concomitant devices were a sheath introducer (5fr25 super sheath), a guiding catheter (5fr65 shepherd hook hanaco for angio catheter) and enpower detachable control box (dcb2000500).Additional information received indicted that there was no report that the device appeared damaged.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.There was no excessive force applied to the device.There was no report that the procedure was prolonged.
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 phone: (b)(6).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.Complaint conclusion: as reported by the field, during a coil embolization for a renal artery aneurysm, a logos balloon catheter and an unspecified coiling support microcatheter (mc) were used.The complaint coil, a 8mmx30cm micrusframe coil (mfr180830, 30393168) was used as first coil.It was inserted into the microcatheter as it was pressed against the hub of the microcatheter, but there was a resistance felt before it came out inside blood vessel.It was re-sheathed but the coil part got prematurely detached in a concomitant microcatheter.The microcatheter was replaced with another one (coiling support) and a micrusframe coil (mfrs180830, unknown lot) was used as second coil without any problems.After that, the procedure completed with another different sized targetxl coil(s).There was no patient injury reported.A continuous flush was done.Concomitant devices were a sheath introducer (5fr25 super sheath), a guiding catheter (5fr65 shepherd hook hanaco for angio catheter) and enpower detachable control box (dcb2000500).Additional information received indicted that there was no report that the device appeared damaged.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.There was no excessive force applied to the device.There was no report that the procedure was prolonged.The device was disagreed; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device 30393168 number, and no non-conformances related to the malfunction were identified.Resistance/friction and premature detachment in microcatheter during removal are known potential issues associated with the use of the device.The instructions for use (ifu) states that continuous infusion of an appropriate flush solution is required for optimal performance, and also indicates that the flush should be verified in the event of resistance.Insufficient flush allows blood to back-flow into the microcatheter, which can cause resistance.The ifu gives instructions for when resistance is felt during delivery of the device.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.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of stretching and premature detachment.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.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: MICRUSFRAME18 8MM X 30CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13757513
• Report Number: 3008114965-2022-00202
• Device Sequence Number: 5936476
• Product Code: KRD
• UDI-Device Identifier: 10886704078210
• UDI-Public: 10886704078210
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

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: 04/30/2023
• Device Model Number: MFR180830
• Device Catalogue Number: MFR180830
• Device Lot Number: 30393168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2022
• Initial Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5FR25 SUPER SHEATH; ENPOWER DCB 2; GUIDING CATHETER (5FR65 SHEPHERD HOOK HANACO); LOGOS BALLOON CATHETER
• Patient Sex: Unknown