MAUDE Adverse Event Report: BIOPTIMAL INTERNATIONAL PTE. LTD. 6F PULMONARY ARTERY MONITORING CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 497527

Device Problem Failure to Advance (2524)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2023

Event Type  malfunction  

Event Description

Swann ganz catheter inserted but would not advance to allow capture of a wedge pressure, so a swann wire was opened and inserted through catheter, but wire would not advance past the hub.

• Brand Name: 6F PULMONARY ARTERY MONITORING CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): BIOPTIMAL INTERNATIONAL PTE. LTD.
• MDR Report Key: 17108262
• MDR Text Key: 317126362
• Report Number: MW5118316
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/06/2023

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: 497527
• Device Catalogue Number: 497527
• Device Lot Number: H220500104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1