MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL PRESIDIO 10 CERE 6MMX26CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	PC4100626-30
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during a stent-assisted aneurysm embolization of the middle cerebral artery (m1 segment), a presidio 10 cere 6mmx26cm coil (pc410062630, 30399457) became impeded in hub part when it trying to advance within an echelon10 microcatheter (mc) during general anesthesia surgery.The physician retracted it (coil was not used in patient) and replaced it with a presidio 10 cere 5mmx17cm coil.The new coil detached without changing the microcatheter.There was not patient injured reported.Additional information received indicated that there was no damage to the mc at any time.The complaint coil did not appear damaged at any time.There was nothing 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.Based on the product analysis of the device received, the embolic coil is stretched.
Additional Manufacturer Narrative
Product complaint # (b)(4).The embolic coil was noted as being stretched, meeting regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).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 stent-assisted aneurysm embolization of the middle cerebral artery (m1 segment), a presidio 10 cere 6mmx26cm coil (pc410062630, 30399457) became impeded in hub part when it trying to advance within an echelon10 microcatheter (mc) during general anesthesia surgery.The physician retracted it (coil was not used in patient) and replaced it with a presidio 10 cere 5mmx17cm coil.The new coil detached without changing the microcatheter.There was not patient injured reported.Additional information received indicated that there was no damage to the mc at any time.The complaint coil did not appear damaged at any time.There was nothing 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 unit presidio 10 cere 6mmx26cm was received inside of a pouch.The device was visually inspected, and it was found that the introducer is separated from the rest of the device without damages.No other damages or anomalies were observed on the device during the visual analysis.The presidio 10 cere 6mmx26cm was inspected under microscope and it was noted that the embolic coil is stretched.The functional test could not be performed due to the introducer was found separated from the rest of the device.Also, the embolic coil was found stretched.A manufacturing record evaluation (mre) was performed for the finished device 30399457 number, and no non-conformances related to the reported complaint condition were identified.Cerenovus conducted a visual and microscopic inspection.The functional test could not be performed due to the conditions in which the device was returned.During the visual analysis of the device, it was noted that the introducer is separated from the rest of the device without damages, due to the separated condition the functional test could not be performed, due this condition the customer complaint regarding ¿detachable coil delivery system (dcs) - impeded in microcatheter with no loss of cerebral target position¿ was confirmed.During the microscopic inspection the embolic coil was found stretched.The stretched condition observed on the embolic coil could be the result of the impeded experience by the customer at the procedure time, however this cannot be conclusively determined.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 is multifactorial.The instructions for use (ifu) do contain the following precautions: ¿ if unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.After flushing, reinsert the introducer into the infusion catheter hub as described in ¿microcoil placement¿ section above.¿ 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 repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil system.¿ if the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.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.An embolic coil becomes stretched when an excessive pull force is applied to the device, it is possible that it might have been caused by the resistance noted in the event description.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.

• Brand Name: PRESIDIO 10 CERE 6MMX26CM
• 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: 12561143
• Report Number: 3008114965-2021-00481
• Device Sequence Number: 13839796
• Product Code: HCG
• UDI-Device Identifier: 00878528003021
• UDI-Public: 00878528003021
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002056
• 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
• Report Date (Section B): 07/14/2021

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: No Information
• Device Expiration Date: 05/31/2025
• Device Model Number: PC4100626-30
• Device Catalogue Number: PC410062630
• Device Lot Number: 30399457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ECHELON10 MICROCATHETER
• Patient Age: 62 YR