MAUDE Adverse Event Report: ICU MEDICAL, INC. UNSPECIFIED 4 LUMEN TD (THERMODILUTION) CATHETER; CATHETER, OXIMETER, FIBER-OPTIC

Catalog Number 412230401

Device Problems Difficult or Delayed Positioning (1157); Difficult to Insert (1316)

Patient Problems Hemoptysis (1887); Hemorrhage/Bleeding (1888)

Event Date 08/22/2022

Event Type  Injury  

Event Description

The event involved an unspecified 4 lumen td (thermodilution) catheter.During cardiomems implant procedure, the patient experienced hemoptysis.The physician believed the guidewire advanced too far when the swan-ganz catheter was introduced into the patient.The patient's head was elevated, and the hemoptysis resolved without further intervention.A ct-angiogram was captured and revealed an arterial hemorrhage.The patient was kept overnight for observation and was discharged the following day.No further details are available at this time.

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

• Brand Name: UNSPECIFIED 4 LUMEN TD (THERMODILUTION) CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 s. atherton drive; salt lake city UT 84123
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 15506723
• MDR Text Key: 300874755
• Report Number: 1713468-2022-00006
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 412230401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 10/17/2022
• Supplement Dates FDA Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED, CARDIOMEMS MONITOR, MF ABBOTT
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening