MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES INC. SPIN ACCESS CATHETER ALWAYS-ON TIP TRACKED GUIDEWIRE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number INS-5950

Device Problem Failure to Advance (2524)

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

Event Date 03/18/2021

Event Type  malfunction  

Event Description

During veran navigational bronchoscopy, the locatable guide would not pass at the distal end of the catheter.Another package had to be opened the worked properly.Initial device did not touch patient.

• Brand Name: SPIN ACCESS CATHETER ALWAYS-ON TIP TRACKED GUIDEWIRE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES INC.; 1938 innerbelt business center dr; saint louis MO 63114
• MDR Report Key: 11893292
• MDR Text Key: 252965885
• Report Number: 11893292
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INS-5950
• Device Catalogue Number: INS-5950
• Device Lot Number: 85490200805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1