MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME14 7MMX11CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR140711
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during an intracranial coil embolization, a cerenovus coil was placed without trouble and then a micrusframe14 7mmx11cm coil (mfr140711, lot unknown) was being used as the second coil.However, the coil could not be advanced within preshaped prowler14 microcatheter (606151fx, lot unknown).Thus, the coil and the mc had to be withdrawn.A new cerenovus coil was used with a new mc and the procedure was completed.Additional information received indicated that the coil did not appear damaged, it could simply not be pushed any further within the microcatheter.After advancement was not possible, withdrawal was tried but also impossible, the coil got stuck.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.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 device advancement.No excessive force was applied to the device.
Additional Manufacturer Narrative
(b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Lot: the lot number was not reported.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ as the reason for non-evaluation.If the device returns, a device investigation will be performed.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.This is one of two products involved with the complaint and the associated manufacturer report number is 3008114965-2022-00025.
Additional Manufacturer Narrative
Product complaint #(b)(4).The lot number of the involved product, the manufacturing and expiration dates were inadvertently omitted on the initial medwatch report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch: b4, d9, g3, g6, h2, h3 and h10.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
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 intracranial coil embolization, a cerenovus coil was placed without trouble and then a micrusframe14 7mmx11cm coil (mfr140711, l17027) was being used as the second coil.However, the coil could not be advanced within preshaped prowler14 microcatheter (606151fx, 30490149).Thus, the coil and the mc had to be withdrawn.A new cerenovus coil was used with a new mc and the procedure was completed.Additional information received indicated that the coil did not appear damaged, it could simply not be pushed any further within the microcatheter.After advancement was not possible, withdrawal was tried but also impossible, the coil got stuck.Nothing was noted to be obstructing the microcatheter.A continuous flush on the microcatheter was maintained.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 device advancement.No excessive force was applied to the device.A non-sterile prowler-14 dual marker unit was received in a pouch.Upon arrival it was noticed that microcatheter was accordionated on its distal part and embolic coil micrusframe14 7mmx11cm was stuck inside.Further inspection revealed a bump at 44 inches from the proximal end of the microcatheter.Device was dissected and core wire of the micrusframe14 7mmx11cm was found to be bent inside of the microcatheter.The micrusframe14 7mmx11cm was pulled out of the microcatheter and embolic coil was found in good conditions.No signs of heating were noticed on the resistance heater (rh).A manufacturing record evaluation was performed, and no non-conformances related to the complaint were found during the review.The product was returned to cerenovus for evaluation.Upon arrival, prowler-14 dual marker was visually inspected, and it was found to be accordioned at its distal portion.Additionally, it was noticed that micrusframe14 7mmx11cm was still stuck inside the microcatheter.A bump was noticed at 44 inches from the proximal end of the microcatheter and a dissection was performed.The core wire from the micrusframe14 7mmx11cm was found bent near the marker band inside the microcatheter.Distal portion of the micrusframe14 7mmx11cm was pulled out of the microcatheter and inspected under microscope.Embolic coil was observed in good conditions.No signs of heating were noticed on the resistance heater (rh).The customer complaint was confirmed due to the findings observed.However, the event description and device analysis do not provide clear insight into the root cause and/or exact contributing factors that may have resulted in the observed failure mode.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Impeded in microcatheter is a known potential product failure associated with the use of the device.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following precautions: ¿ if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.¿ 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.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 failures and damages on the returned system.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MICRUSFRAME14 7MMX11CM
• 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: 13235372
• Report Number: 3008114965-2022-00024
• Device Sequence Number: 4307471
• Product Code: KRD
• UDI-Device Identifier: 10886704079347
• UDI-Public: 10886704079347
• Combination Product (Y/N): N
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/02/2022

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: 08/31/2022
• Device Model Number: MFR140711
• Device Catalogue Number: MFR140711
• Device Lot Number: L17027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Supplement Date Received by Manufacturer: 01/13/2022; 01/24/2022; 02/27/2022
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 01/13/2022; 02/09/2022; 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2019
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRESHAPED PROWLER14 45TIP 2MRK
• Patient Sex: Unknown