MAUDE Adverse Event Report: MICROVENTION INC. SOFIA-5F EX; PERCUTANEOUS CATHETER

Model Number	ISC5115ST-MVI
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2024
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 investigation of the returned catheter system found no damage along the surface of the device; however, ptfe liner was found occluding the lumen, which is consistent with the advancement issue described in the reported event.A segment of the occlusion was heat-tested with 500f hot air and did not melt or deform, confirming that the material is ptfe.The physical evaluation of the device could not identify the conditions or circumstances that led to the ptfe liner damage, but the damage is consistent with the device experiencing forces over specification.The headway microcatheter and guidewire used in the procedure were not returned for evaluation, so the investigation could not determine if they had caused or contributed to the reported complaint.
Event or Problem Description
While preparing the sofia device on the back table, the microcatheter would not advance through the sofia ex.The operator then attempted to advance just a wire, but that also would not advance.The sofia was not used and was replaced with a competitor device.Additional information from the post-evaluation report revealed that a ptfe liner was found to be occluding the lumen, which is in line with the described advancement issue in the reported event.

• Brand Name: SOFIA-5F EX
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; 7142478000
• MDR Report Key: 20177479
• Report Number: 2032493-2024-00672
• Device Sequence Number: 8722913
• Product Code: DQY
• UDI-Device Identifier: 00842429101582
• UDI-Public: (01)00842429101582(11)240301(17)270228(10)0000535334
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K182602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

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 Model Number: ISC5115ST-MVI
• Device Lot Number: 0000535334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2024
• 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: 08/14/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: 54 YR
• Patient Sex: Female