MAUDE Adverse Event Report: ICU MEDICAL, INC VIP SWAN; CATHETER, FLOW DIRECTED

Model Number 0840619

Device Problem Inflation Problem (1310)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2019

Event Type  malfunction  

Event Description

Upon needing a right heart catheter, the vip swan was prepped in normal fashion.While checking the integrity of the balloon via inflation of the balloon with the supplied 3 ml syringe, it would not inflate much at all.It was tried several times to get it to inflate, but it didn't have much integrity.Another balloon was used and worked fine (lot # 4145480 new device).

• Brand Name: VIP SWAN
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ICU MEDICAL, INC; 4455 atherton dr; salt lake city UT 84123
• MDR Report Key: 9659312
• MDR Text Key: 177373542
• Report Number: 9659312
• Device Sequence Number: 1
• Product Code: DYG
• 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: 10/25/2019,10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0840619
• Device Lot Number: 4123595
• 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: 10/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25185 DA