MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3.5X7.5; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX3575
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.The delivery tube (hypo tube) was found broken.The findings meet regulatory reporting criteria.Procode: krd/hcg initial reporter: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.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.Complaint conclusion: as reported by the field, during a coil embolization, a 3.5x7.5 orbit galaxy xtrasoft coil (640cx3575, 30355739) was being used as the third coil.The physician felt strong resistance during advancing the orbit galaxy coil through headway microcatheter (mc).The coil was removed and a same like product was used.The procedure was successfully finished.There was no patient injury reported.No additional information is available.A non-sterile unit og cmplx xtrasoft coil 3.5x7.5 was received inside of a pouch.The device was visually inspected, and it was noted that the hypo-tube is broken in two parts, also it was noted several kinked, no other damages or anomalies were observed on the device during the visual analysis.The device was inspected under a microscope and it was found that the embolic coil is in good normal conditions.The functional test could not be performed due to the broken condition observed on the hypo-tube.Due to the broken condition noted on the hypo-tube a scanning electron microscope (sem) testing was performed, the results of the scanning electron microscope (sem) test are the following.There is evidence of mechanical damage and stress marks on hypo-tube.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 (mre) was performed for the finished device 30355739 number, and no non-conformances related to the reported complaint condition were identified cerenovus conducted a visual 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 hypo-tube was observed broken in two a scanning electron microscope (sem) testing was performed.During the visual analysis of the device, it was noted that the hypo-tube for the og cmplx xtrasoft coil 3.5x7.5 is broken in two, also it was noted several kinked, the several kinked condition could be related with the resistance/friction experience by the customer at the procedure time, also it could be related with the broken condition noted on the hypo-tube, however this cannot be conclusively determined.Based on the findings during the analysis, the customer complaint was confirmed.The microscopic inspection revealed that the embolic coil is in good normal conditions inside the introducer.The scanning electron microscope (sem) testing showed evidence of mechanical damage and stress marks on hypo-tube.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.Resistance/friction-during advancement is a known complication when using this device.It should be noted that product failure is multifactorial.The instructions for use (ifu) do contain the following directions: ¿ 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.The detachable coils are delicate and must be handled carefully.Prior to use and when possible during the procedure, inspect the system for bends or kinks.Do not use a coil system showing signs of damage.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.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 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.
Event or Problem Description
As reported by the field, during a coil embolization, a 3.5x7.5 orbit galaxy xtrasoft coil (640cx3575, 30355739) was being used as the third coil.The physician felt strong resistance during advancing the orbit galaxy coil through headway microcatheter (mc).The coil was removed and a same-like product was used.The procedure was successfully finished.There was no patient injury reported.No additional information is available.Based on the product analysis of the device received, the delivery tube (hypo tube) was found broken.

• Brand Name: OG CMPLX XTRASOFT COIL 3.5X7.5
• 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: 12563443
• Report Number: 3008114965-2021-00483
• Device Sequence Number: 1547514
• Product Code: KRD
• UDI-Device Identifier: 10886704030706
• UDI-Public: 10886704030706
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2021

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: 12/31/2021
• Device Model Number: 640CX3575
• Device Catalogue Number: 640CX3575
• Device Lot Number: 30355739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/01/2021
• 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