MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FILL COIL 4X10; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CF0410
Medical Device Problem Codes	Retraction Problem (1536); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
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.The device was discarded therefore no product investigation can be performed.A manufacturing record evaluation was performed for the finished device 30379639 number, and no non-conformances related to the reported complaint condition were identified.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, a 4x10 og tdl cmplx fill coil (640cf0410, 30379639) was being used as the first coil.The physician felt strong resistance during advancing the orbit galaxy coil through headway microcatheter (mc).The coil was jammed inside of the catheter and not available to be taken out of the catheter.The physician used a same like product.The procedure was successfully finished.There was no report of patient injury.
Additional Manufacturer Narrative
Product complaint (b)(4).Updated sections on this medwatch report: b5, g3, g6, h2 and h10.Section b5: additional information received indicated that no other devices were used with the mc prior to the encountered resistance.The event did not result in a loss of cerebral target position.The device was removed from the patient without additional intervention.It was reported that the mc jammed itself during manipulation.No other component was noticed damaged.The catheter was successfully removed outside of the body without any injury.But they couldn't move the coil outside of the catheter due to resistance.There was nothing obstructing the microcatheter.The continuous flush on the microcatheter was maintained.The introducer flushed until the 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 significant prolongation in the procedure due to the event.The procedure was ¿delayed little bit¿ due to removing the catheter and re prepare the new coil and catheter.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, a 4x10 og tdl cmplx fill coil (640cf0410, 30379639) was being used as the first coil.The physician felt strong resistance during advancing the orbit galaxy coil through headway microcatheter (mc).The coil was jammed inside of the catheter and not available to be taken out of the catheter.The physician used a same like product.The procedure was successfully finished.There was no report of patient injury.Additional information received indicated that no other devices were used with the mc prior to the encountered resistance.The event did not result in a loss of cerebral target position.The device was removed from the patient without additional intervention.It was reported that the mc jammed itself during manipulation.No other component was noticed damaged.The catheter was successfully removed outside of the body without any injury.But they couldn't move the coil outside of the catheter due to resistance.There was nothing obstructing the microcatheter.The continuous flush on the microcatheter was maintained.The introducer flushed until the 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 significant prolongation in the procedure due to the event.The procedure was ¿delayed little bit¿ due to removing the catheter and re prepare the new coil and catheter.The device was discarded therefore no product investigation can be performed.A manufacturing record evaluation was performed for the finished device 30379639 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 complaints of ¿detachable coil delivery system (dcs) - resistance/friction-during advancement with no loss of cerebral target position¿ and ¿coil - withdrawal difficulty-into microcatheter¿ 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.Resistance/friction and withdraw difficulty are known potential issues associated with the use of the device.The instructions for use (ifu) caution that if unusual friction is still noticed during advancement or retraction of the coil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire catheter system and examine for damage.Replace it with a new system.If friction still exists, withdraw and examine the delivery catheter system.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 suggest the events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: OG TDL CMPLX FILL COIL 4X10
• 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: 11154305
• Report Number: 3008114965-2021-00014
• Device Sequence Number: 3940913
• Product Code: KRD
• UDI-Device Identifier: 10886704030263
• UDI-Public: 10886704030263
• Combination Product (Y/N): N
• PMA/510(K) Number: K093973
• 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): 12/21/2020

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: 02/28/2022
• Device Model Number: 640CF0410
• Device Catalogue Number: 640CF0410
• Device Lot Number: 30379639
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 02/16/2021
• 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: HEADWAY MICROCATHETER