MAUDE Adverse Event Report: MIRCOVENTION, INC. HYDROSOFT-10-AV; COILS

Model Number	100310H2HS-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies premature coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during coiling of an aneurysm, the aneurysm was treated with 3d coils.When the physician had another coil passed to him, the assistant accidentally passed a helical coil and not a 3d coil.This helical coil 3/10mm was also placed in the aneurysm.The physician then decided to take the helical coil out.While trying to retrieve the coil, the coil detached itself.The detached coil was easily retrieved with a catch mini retrieval device and echelon catheter.The patient is reported to be doing well.

• Brand Name: HYDROSOFT-10-AV
• Common Device Name: COILS
• Manufacturer (Section D): MIRCOVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 19620276
• Report Number: 2032493-2024-00500
• Device Sequence Number: 12370617
• Product Code: HCG
• UDI-Device Identifier: 00816777022943
• UDI-Public: (01)00816777022943(11)230518(17)280430(10)0000366854
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 100310H2HS-V-A2
• Device Lot Number: 000036685
• Was Device Available for Evaluation?: No
• 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: 06/12/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown