MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL UNK COIL-THERMO MECHANICAL; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR181647
Medical Device Problem Codes	Positioning Problem (3009); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
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 phone ¿ (b)(6).The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
As reported by the field, during a coil embolization, a 16mm x 47cm micrusframe18 coil (mfr181647, k10015) was attempted to come out from the tip of a concomitant microcatheter (1.9fr carnelian marvel, tokai medical products) but the microcatheter kicked back.The physician attempted to retract the complaint coil but it detached.The tip of the complaint coil was inside the microcatheter (mc) therefore, the coil was removed with the microcatheter together.The microcatheter was replaced with another microcatheter (same catalog number/ different lot number) and the complaint coil was replaced with a competitive coil and the procedure continued.There was no patient injury reported.Additional information was received indicating that there was no excessive force used with trying to retract the micrusframe18 16mm x 47cm.Adequate flush was maintained through the devices.There was no significant prolongation in the procedure due to the event.
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.The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Product complaint # (b)(4).Updated sections on this medwatch report: g3, g6, h2, h3, h6, h10 and h11.Complaint conclusion: as reported by the field, during a coil embolization, an unknown -thermo mechanical coil was attempted to come out from the tip of a concomitant microcatheter (1.9fr carnelian marvel, tokai medical products) but the microcatheter kicked back.The physician attempted to retract the complaint coil, but it detached.The tip of the complaint coil was inside the microcatheter therefore, the coil was removed with the microcatheter together.The microcatheter was replaced with another microcatheter (same catalog number/ different lot number) and the complaint coil was replaced with a competitive coil and the procedure continued.Additional information was received indicating that there was no excessive force used with trying to retract the coil.Adequate flush was maintained through the devices.There was no significant prolongation in the procedure due to the event.A non-sterile unk coil-thermo mechanical was received inside of a pouch with a non-johnson & johnson microcatheter.The unk coil-thermo mechanical was inspected, and it was found that the dpu is kinked at 25 cm, 32 cm, and 69 cm from proximal, also it was noted that the embolic coil is not attached to the device.No other damages or anomalies were observed during the visual inspection.The marker band was found at 84.5 cm from the hub, this suggests that the length of the embolic coil is within specification.The device was inspected under a microscope and it was noted that the rh is heated, this is related to the detached condition of the embolic coil.The non-johnson & johnson microcatheter was inspected under x-ray in order to appreciate if the embolic coil is stuck inside it.During the x-ray was observed that the coil is inside the microcatheter with a stretch and knotted condition.The lot number is not known; therefore, a device history record review cannot be completed.The conditions previously mentioned could be related to the customer complaint and appear that might have been caused by excessive force and/or handling applied to the device, however, this cannot conclusively determine.It should be noted that product failure is multifactorial.Based on the information currently available, the customer complaint of ¿coil - premature detachment-in mc during removal¿ was confirmed.Premature detachment is a known potential product failure associated with the use of the device.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 failure and damages on the returned system.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.Based on clarification from the account received on 16-feb-2021, the product/lot number for the device involved/received for this complaint is not available.Therefore, section d1: brand name was updated to "unk coil-thermo mechanical".Section d4; catalog was updated to "unk coil-thermo mechanical".

• Brand Name: UNK COIL-THERMO MECHANICAL
• 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: 11163252
• Report Number: 3008114965-2021-00019
• Device Sequence Number: 17025769
• Product Code: KRD
• UDI-Device Identifier: 10886704078135
• UDI-Public: 10886704078135
• 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,Followup,Followup
• Report Date (Section B): 12/22/2020

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: 09/30/2022
• Device Model Number: MFR181647
• Device Catalogue Number: UNK COIL-THERMO MECHANICAL
• Device Lot Number: K10015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 01/20/2021; 02/16/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/09/2021; 03/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.9FR CARNELIAN MARVEL MICROCATHETER.; MICRUSFRAME18 19MM X 50CM.