MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CONTROLCATH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number C146F7

Device Problems Hole In Material (1293); Inflation Problem (1310)

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

Event Date 09/18/2017

Event Type  malfunction  

Event Description

Doctor tested balloon in flush bowl prior to insertion into patient.Balloon tested appropriately, held water and deflated appropriately.Doctor inserted balloon through 12fr sheath, advanced swan, unable to inflate balloon.Removed swan from patient and retested balloon in flush bowl.Balloon had a hole.Doctor called for another swan, same latex free swan with different lot number.Balloon worked prior to insertion but again had a hole in it after inserted and removed through 12fr sheath.Doctor pretreated patient for latex allergy, called for latex swan, balloon inflated without any problems.

• Brand Name: SWAN-GANZ CONTROLCATH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6913717
• MDR Text Key: 88156140
• Report Number: 6913717
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/27/2017

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: No Information
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Other Device ID Number: 60891023/60921831
• 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: 09/27/2017
• Event Location: Other
• Date Report to Manufacturer: 09/27/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR