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

Model Number	C146F7
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of hypertension, stage iii chronic kidney disease and recent chest pain and shortness of breath.While having a diagnostic heart cath, the balloon of the swan ruptured and was removed intact.A new swan was inserted, without known harm to the patient.

• Brand Name: SWAN-GANZ CONTROLCATH
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• MDR Report Key: 11633425
• Report Number: 11633425
• Device Sequence Number: 3683567
• Product Code: DQO
• UDI-Device Identifier: 00690103153132
• UDI-Public: (01)00690103153132(17)230305(11)210305(10)63662592
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/06/2021
• Report Date (Section F): 04/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: C146F7
• Device Catalogue Number: C146F7
• Device Lot Number: 63662592
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2021
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Weight: 88
• Date Report Sent to FDA: 04/06/2021