MAUDE Adverse Event Report: MICROVENTION, INC AZUR CX 35 DETACHABLE; PERIPHERAL

Model Number	45-750812
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
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.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the coil got stuck inside the catheter.It detached half inside the catheter, half outside the catheter, in the patient¿s body.The physician was able to remove the coil and catheter safely and used another coil to complete the case.The procedure was successful and no reported injury to the patient.
Additional Manufacturer Narrative
The investigation of the returned coil system found the pusher returned with no implant attached, and the gold connector kinked.The severed implant was not returned for evaluation as the proximal portion remained in the microcatheter and the distal portion remained in the patient as described in the reported event.The pusher's heater coil showed no signs of activation using a detachment controller.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
See section h:10.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: PERIPHERAL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): NYU LANGONE; 550 1st avenue; new york NY 11016
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15965268
• Report Number: 2032493-2022-00545
• Device Sequence Number: 4913191
• Product Code: KRD
• UDI-Device Identifier: 00812636021058
• UDI-Public: (01)00812636021058(11)211011(17)260930(10)0000100309
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162524
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2022

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: 09/30/2026
• Device Model Number: 45-750812
• Device Catalogue Number: 45-750812
• Device Lot Number: 0000100309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2022
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 55 KG