MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5 FR X 16 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-42854-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Respiratory Distress (2045)

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

Continuation of medical devices: ent.(b)(4).

Event Description

It was reported that the patient transferred to intensive cardiac care, with a right internal jugular venous catheter, arterial femoral catheter and dialysis catheter in the right femoral position.The incident happened in the intensive cardiac care unit.There was a respiratory distress during the removal of the right internal jugular venous catheter around 6pm.An immediate cardiac x ray was performed , and the result was there was a right heart failure with presence of bubbles in the right cavities.A non-invasive ventilation was performed.Clinical consequences: the diagnosis was a severe air embolism during removal of the catheter.The gradual improvement of the clinical condition of the female patient allowed her to out of intensive care for the continuation of the treatment.The patient left the hospital and went back home.

Manufacturer Narrative

Concomitant medical products: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that the patient transferred to intensive cardiac care, with a right internal jugular venous catheter, arterial femoral catheter and dialysis catheter in the right femoral position.The incident happened in the intensive cardiac care unit.There was a respiratory distress during the removal of the right internal jugular venous catheter around 6pm.An immediate cardiac x ray was performed , and the result was there was a right heart failure with presence of bubbles in the right cavities.A non-invasive ventilation was performed.Clinical consequences: the diagnosis was a severe air embolism during removal of the catheter.The gradual improvement of the clinical condition of the female patient allowed her to out of intensive care for the continuation of the treatment.The patient left the hospital and went back home.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5 FR X 16 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7837295
• MDR Text Key: 119047481
• Report Number: 3006425876-2018-00572
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2018

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?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/21/2020
• Device Catalogue Number: CS-42854-E
• Device Lot Number: 71F18E2266
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2018
• Initial Date FDA Received: 08/31/2018
• Supplement Dates Manufacturer Received: 10/05/2018
• Supplement Dates FDA Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ADDITIONAL INVASIVE CATHETERS INSERTED IN THE PATI; ADDITIONAL INVASIVE CATHETERS INSERTED IN THE PATI
• Patient Outcome(s): Required Intervention