MAUDE Adverse Event Report: MICROVENTION INC. AZUR CX DETACHABLE; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-780828
Medical Device Problem Codes	Break (1069); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported: during splenic pseudoaneurysm coiling, they had an 8x28 coil break inside the microcatheter while trying to recapture the coil.Coil was removed.The case was completed & the patient left the procedure in stable condition.No other information was provided.
Additional Manufacturer Narrative
A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Upon review of device registration and previous mdr submitted to the fda, discrepancies were noted.Clarification was received regarding the device registration and the following fields have been corrected: d1.D3.D4.H11: investigation findings items returned for evaluation: -pusher -implant -introducer.Items not returned for evaluation: -shrink lock -dispenser hoop -microcatheter.The visual analysis of the returned items found that the implant was not attached to the pusher, but no signs of activation were observed on the pusher heater coil , and the pusher was kinked at the distal section.The implant was found separated from the pusher and stuck inside the introducer, with observed blood residue.Further inspection found the introducer distal tip damaged.The implant was retrieved from the introducer and found to be kinked and deformed at the distal section.The investigation found the pusher's monofilament broken, which indicates that the device experienced a tensile break.Investigation conclusion: the investigation of the returned coil system found the pusher kinked at the distal section, the implant kinked and deformed at the distal section, and the implant separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The inspection of the introducer found damage at the distal tip, and combined with the damages to the implant, the cause of the reported event is consistent with the implant becoming stuck at the introducer distal tip during retraction.The physical evaluation of the device could not identify the conditions or circumstances that led to the implant and pusher damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
No additional information was received, please see h6 and h11.

• Brand Name: AZUR CX DETACHABLE
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19463974
• Report Number: 2032493-2024-00442
• Device Sequence Number: 12427552
• Product Code: KRD
• UDI-Device Identifier: 00810170018336
• UDI-Public: (01)00810170018336(11)210104(17)251231(10)2101045ZA
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K123384
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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: 12/31/2025
• Device Model Number: 45-780828
• Device Lot Number: 2101045ZA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White