MAUDE Adverse Event Report: MICROVENTION, INC SOFIA 5FR; PERCUTANEOUS CATHETER

Model Number	DA5115ST
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2022
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 analysis.The investigation is ongoing.
Event or Problem Description
It was reported that when negative pressure was applied to a sofia catheter, air bubbles appeared near a pinhole leak neat the hub.It was not used and there was no injury to the patient.
Additional Manufacturer Narrative
The investigation of the returned device was not able to replicate bubbles, however further examination of the device found that there was a gap in adhesive which was clogged with dried blood.Air could've flowed through the hole to created bubbles at the time of the reported event.This findings from this investigation have been communicated to quality.

• Brand Name: SOFIA 5FR
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14710862
• Report Number: 2032493-2022-00238
• Device Sequence Number: 13997226
• Product Code: DQY
• UDI-Device Identifier: 00812636020082
• UDI-Public: (01)00812636020082(11)220121(17)241231(10)0000149195
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131482
• 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): 05/26/2022

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: 12/31/2024
• Device Model Number: DA5115ST
• Device Catalogue Number: DA5115ST
• Device Lot Number: 0000149195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 06/16/2022
• Supplement Report FDA Received Date: 09/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• 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: 35 YR
• Patient Sex: Female