MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 7X25; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CR0725
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
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.If the device returns, a device investigation will be performed.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 3008114965-2021-00303.
Event or Problem Description
As reported by the field, during a coil embolization, a 7x25 orbit galaxy complex frame coil (640cr0725, 30337722) and an 8x30 orbit galaxy coil (640cr0830, 30286063) were not moving properly in the unspecified microcatheter.There was so much of resistance in deploying the coils.Both the coil and catheter were removed without additional intervention, there was a loss of cerebral target position.Another coil and catheter were used.The surgery was delayed by 15 minutes due to the event.The procedure was successfully completed.The patient was ¿fine¿ after the procedure.No additional information is available.
Additional Manufacturer Narrative
Product complaint # (b)(4).Complaint conclusion: as reported by the field, during a coil embolization, a 7x25 orbit galaxy complex frame coil (640cr0725, 30337722) and an 8x30 orbit galaxy coil (640cr0830, 30286063) were not moving properly in the unspecified microcatheter.There was so much of resistance in deploying the coils.Both the coil and catheter were removed without additional intervention, there was a loss of cerebral target position.Another coil and catheter were used.The surgery was delayed by 15 minutes due to the event.The procedure was successfully completed.The patient was ¿fine¿ after the procedure.No additional information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device 30337722 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 - resistance/friction-during advancement with loss of cerebral target position¿ could not be confirmed.Based on the manufacturing record evaluation, device history record review, there is no indication that the event is related to the device manufacturing process.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 event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices 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 issue.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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.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).Updated section on this medwatch report: 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 updated with product analysis: as reported by the field, during a coil embolization, a 7x25 orbit galaxy complex frame coil (640cr0725, 30337722) and an 8x30 orbit galaxy coil (640cr0830, 30286063) were not moving properly in the unspecified microcatheter.There was so much of resistance in deploying the coils.Both the coil and catheter were removed without additional intervention, there was a loss of cerebral target position.Another coil and catheter were used.The surgery was delayed by 15 minutes due to the event.The procedure was successfully completed.The patient was ¿fine¿ after the procedure.No additional information is available.A non-sterile unit og tdl cmplx frame coil 7x25 was returned to cerenovus for evaluation.Cerenovus conducted visual inspection and microscopic inspection.The functional test of the device could not be performed due to the conditions in which the device was returned for evaluation.Since the gripper was observed broken in two a scanning electron microscope (sem) testing was performed.A manufacturing record evaluation was performed for the finished device 30337722 number, and no non-conformances related to the reported complaint condition were identified.During the visual analysis of the device, it was noted that device is severely kinked, also the gripper for the og tdl cmplx frame coil 7x25 is broken in two.Procedural and other factors such as device interaction and device manipulation may have contributed to the finding; however, this cannot be conclusively determined.Due to the broken condition noted on the gripper, the functional test of the product complaint regarding ¿detachable coil delivery system (dcs) - resistance/friction-during advancement with loss of cerebral target position¿, based on the findings during the analysis, the customer complaint was confirmed.The microscopic inspection revealed that the embolic coil is in good normal inside the introducer.Due to the broken condition noted on the gripper a a scanning electron microscope (sem) testing was performed, the results of the scanning electron microscope (sem) test are as follows: it was noted evidence of mechanical damage and stress marks on the gripper.These damages could be related to the handling of the device during the procedure or excessive force; however, this cannot be conclusively determined.No other anomalies were observed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: ¿ 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.¿ if unusual friction is noted within the infusion catheter, remove the detachable coil system.¿ if friction is noted with any subsequent detachable coil system, carefully examine the detachable coil system and the infusion catheter for possible damage.Replace both if necessary.Assignment of root cause for the events 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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: OG TDL CMPLX FRAME COIL 7X25
• 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. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12166198
• Report Number: 3008114965-2021-00302
• Device Sequence Number: 3821163
• Product Code: KRD
• UDI-Device Identifier: 10886704030447
• UDI-Public: 10886704030447
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/14/2021

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: 11/30/2021
• Device Model Number: 640CR0725
• Device Catalogue Number: 640CR0725
• Device Lot Number: 30337722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 09/01/2021; 11/19/2021; 12/10/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/14/2021; 12/07/2021; 12/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2019
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OG TDL CMPLX FRAME COIL 8X30; UNSPECIFIED MICROCATHTER
• Patient Sex: Unknown