MAUDE Adverse Event Report: MICROVENTION, INC. AZUR-35 DETACHABLE FRAMING COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	45-651434
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
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.Part of the pusher wire has been 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
As reported: during a proximal splenic embo, dr.Had a 30cm sheath in the aorta and a 100cm 4fr angled catheter in the splenic artery.The artery measured 8-9mm in diameter.The first coil used was an 35 14x34 framing coil.Dr.Advanced the coil to the tip of the catheter and it became stuck.Within a few seconds of manipulating the coil, dr.Stated that he felt like the coil broke free.He removed what was left of the pusher wire and injected saline into the catheter to shoot the coil out into the vessel.The coil landed where he wanted, however, a long portion of the pusher wire was still attached to the coil.The wire snapped in half, it wasn't the coil detaching like he suspected.The wire prolapsed into a collateral vessel and tracked all the way back to the origin of the splenic artery.It was noticed that the catheter kinked at the proximal portion of the splenic artery.From there, he decided to continue the procedure and put a 45cm sheath up into the splenic artery along with a new 4fr 100cm angled catheter and continued to deploy six 035 azur cx coils without incident to complete the procedure.No patient injury reported.
Event or Problem Description
As reported: during a proximal splenic embo, dr.Had a 30cm sheath in the aorta and a 100cm 4fr angled catheter in the splenic artery.The artery measured 8-9mm in diameter.The first coil used was an 35 14x34 framing coil.Dr.Advanced the coil to the tip of the catheter and it became stuck.Within a few seconds of manipulating the coil, dr.Stated that he felt like the coil broke free.He removed what was left of the pusher wire and injected saline into the catheter to shoot the coil out into the vessel.The coil landed where he wanted, however, a long portion of the pusher wire was still attached to the coil.The wire snapped in half, it wasn't the coil detaching like he suspected.The wire prolapsed into a collateral vessel and tracked all the way back to the origin of the splenic artery.It was noticed that the catheter kinked at the proximal portion of the splenic artery.From there, he decided to continue the procedure and put a 45cm sheath up into the splenic artery along with a new 4fr 100cm angled catheter and continued to deploy six 035 azur cx coils without incident to complete the procedure.No patient injury reported.
Additional Manufacturer Narrative
Correction: corrected response to "is this a single-use device that was reprocessed and reused on a patient?" in section d.Items returned for evaluation: -pusher.Items not returned for evaluation: -implant.-introducer.-shrink lock.-dispenser hoop.-catheter.The visual analysis of the returned items found that the implant was not attached to the pusher, but no signs of activation using a detachment controller was observed on the heater coil.No damage or other anomaly was observed on the pusher.The implant was not returned for evaluation.The investigation of the pusher found the monofilament broken, indicating that the device experienced a tensile break.The investigation of the returned coil system found the pusher returned without the implant attached, but no indications of activation using a detachment controller was observed on the pusher heater coil.The implant was not returned for evaluation.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.However, without radiographic imaging from the procedure, this investigation could not determine if any part of the coil prolapsed into a collateral vessel as described in the reported event.The catheter used in the procedure was not returned, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: AZUR-35 DETACHABLE FRAMING COIL
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 19707223
• Report Number: 2032493-2024-00526
• Device Sequence Number: 12632445
• Product Code: KRD
• UDI-Device Identifier: 00810170016127
• UDI-Public: (01)00810170016127(11)231114(17)281031(10)0000461801
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K111307
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 08/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 45-651434
• Device Lot Number: 0000461801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2024
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 30CM COOK SHEATH; 4FR ANGLED GLIDECATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown