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

Model Number	45-752039
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	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this 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.  .
Event or Problem Description
It was reported during a coil embolization the catheter was in a tortuous anatomy and placed in splenic artery aneurysm.The coil was in the guide catheter and would not advance.The coil was pulled back and resistance was felt.The coil would not go past curve of the catheter to come out of the catheter.At this point the physician realized that the coil had detached in the catheter.Physician pulled the catheter back which bucked the catheter out of the aneurysm.Had to pull out the guide catheter with detached coil in it.Had to regain celiac access.There was no reported injury and the patient was in good condition.
Additional Manufacturer Narrative
The investigation of the returned coil system found the implant partially advanced through the microcatheter.The implant was retrieved from the microcatheter and was found damaged, deformed, and severely stretched at the proximal section.The pusher was not returned for evaluation.The implant's monofilament showed 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 also evaluated and was found to be kinked at 36cm from the hub, which is consistent with the resistance experienced during advancement as described in the reported event.
Event or Problem Description
N/a.

• Brand Name: AZUR CX 35 DETACHABLE
• Common Device Name: PERIPHERAL
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16549664
• Report Number: 2032493-2023-00621
• Device Sequence Number: 14963162
• Product Code: KRD
• UDI-Device Identifier: 00812636021102
• UDI-Public: (01)00812636021102(11)220929(17)270831(10)0000266816
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K151358
• 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): 02/27/2023

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 Model Number: 45-752039
• Device Catalogue Number: 45-752039
• Device Lot Number: 0000266816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 118 KG