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

Model Number DA5115ST

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 294292214
• Report Number: 2032493-2022-00238
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00812636020082
• UDI-Public: (01)00812636020082(11)220121(17)241231(10)0000149195
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female