MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC SWAN-GANZ CONTROLCATH; CATHETER, FLOW DIRECTED

Model Number C146F7

Device Problem Break (1069)

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

Event Date 12/01/2020

Event Type  malfunction  

Event Description

(b)(6) female for diagnostic cath.In attempting to pass and inflate the latex free swan, the balloon broke.Removed intact without known harm to patient.

• Brand Name: SWAN-GANZ CONTROLCATH
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 10966943
• MDR Text Key: 220192374
• Report Number: 10966943
• Device Sequence Number: 1
• Product Code: DYG
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)220729(11)200729(10)63282717
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 63282717
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1