MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL HELI 10 TP CERE, 7MMX20CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	CHE100720-30
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
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 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.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 a healthcare professional, during a coil embolization, the physician described difficulty/resistance pushing both a 7mmx20cm heli 10 tp cere coil (che10072030, l15303) out of a rapid transit dual marker 150cm microcatheter (601251x, lot unknown).The coil was not deployed.Additional information was received that the resistance was encountered during advancement; the devices were able to move.The resistance was first noticed inside the microcatheter (mc), distal tip as coil exited mc.The coil delivery system was removed through the mc.The event did not result in a loss of cerebral target position.The mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.There was nothing noted obstructing the microcatheter.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force was applied to the device.Based on the analysis of the heli 10 tp cere, 7mmx20cm received, the embolic coil was found with stretch condition.A non-sterile unit heli 10 tp cere, 7mmx20cm was received inside of a pouch.The device was inspected, and it was found that the dpu is kinked, no other damages or anomalies were observed during the visual analysis.The embolic coil was inspected under a microscope and it was found with stretch condition outside the introducer.The functional analysis could not be performed due to embolic coil was found with a stretch, this condition could be related with the customer¿s experience at the procedure time, also, a kinked condition was noted on the dpu.A manufacturing record evaluation was performed for the finished device l15303 number, and no non-conformances related to the reported complaint condition were identified.The complaint reported by the customer ¿coil - resistance/friction-with delivery catheter - no loss of cerebral target position¿ was confirmed, during the microscopic inspection it was noted that the embolic coil is stretched outside the introducer, this condition could be related with the customer¿s experience at the procedure time and appears to might have caused by excessive force and/or handling applied to the device, however, it cannot be determined the exact time when this occurred.Also, the dpu was found kinked, this condition may have been related to handling applied to the device at the procedure timer, however, this cannot be conclusively determined.Neither the analysis nor the mre suggests that the failure reported by the customer could be related to the 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 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.Stretching of the embolic coil occurs when an attempt is made to retract the device while a more distal part of the embolic coil is held in position, possibly by the resistance noted in the event description.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 a healthcare professional, during a coil embolization, the physician described difficulty/resistance pushing both a 7mmx20cm heli 10 tp cere coil (che10072030, l15303) out of a rapid transit dual marker 150cm microcatheter (601251x, lot unknown).The coil was not deployed.Additional information was received that the resistance was encountered during advancement; the devices were able to move.The resistance was first noticed inside the microcatheter (mc), distal tip as coil exited mc.The coil delivery system was removed through the mc.The event did not result in a loss of cerebral target position.The mc was not damaged during manipulation of the coil or noticed to be damaged upon removal from the patient.There was nothing noted obstructing the microcatheter.The tip of the introducer was firmly installed into the hub of the microcatheter and locked with the rhv during coil advancement.No excessive force was applied to the device.Based on the analysis of the heli 10 tp cere, 7mmx20cm received, the embolic coil was found in a stretch condition.

• Brand Name: HELI 10 TP CERE, 7MMX20CM
• 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: 11195766
• Report Number: 3008114965-2021-00037
• Device Sequence Number: 3756318
• Product Code: HCG
• UDI-Device Identifier: 00878528000525
• UDI-Public: 00878528000525
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K022420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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: 02/29/2024
• Device Model Number: CHE100720-30
• Device Catalogue Number: CHE10072030
• Device Lot Number: L15303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1