MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC SET: 3-L 7 FR X 6" (16 CM) AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-42703-PMC-S1

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

Patient Problems Apnea (1720); Coma (2417); Loss of consciousness (2418)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Several attempts made to user facility to obtain additional information regarding the reported event.No response from user facility at the time of this report.

Event Description

According to the medwatch ((b)(4)) "called to bedside as patient deteriorated rapidly during internal jugular central line removal.Patient became stuporous and with agonal breathing, severe hypoxemia ensued and supported him with ambu bag and 100% oxygen immediately.Eyes were noted to be fixed and deviated to upper left and unresponsive to stimuli.Patient then started to breathe spontaneously with normal respiratory effort but remained comatose.Bedside echocardiography revealed significant amount of air bubbles in the right heart.Patient remained comatose through this procedure but started to slowly respond to voice commands, corneal reflexes present and attempts to make spontaneous movements followed".

Event Description

According to the medwatch (b)(4) "called to bedside as patient deteriorated rapidly during internal jugular central line removal.Patient became stuporous and with agonal breathing, severe hypoxemia ensued and supported him with ambu bag and 100% oxygen immediately.Eyes were noted to be fixed and deviated to upper left and unresponsive to stimuli.Patient then started to breathe spontaneously with normal respiratory effort but remained comatose.Bedside echocardiography revealed significant amount of air bubbles in the right heart.Patient remained comatose through this procedure but started to slowly respond to voice commands, corneal reflexes present and attempts to make spontaneous movements followed".

Manufacturer Narrative

Qn# (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.

• Brand Name: ARROW PI CVC SET: 3-L 7 FR X 6" (16 CM) AGB+
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8137830
• MDR Text Key: 129479478
• Report Number: 3003737899-2018-00171
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/21/2018

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?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: ASK-42703-PMC-S1
• Device Lot Number: 13F18G0533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 01/08/2019
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention