MAUDE Adverse Event Report: BOSTON SCIENTIFIC IMPULSE FLEXTRUSION SHAFT, ANGIOGRAPHIC CATHETER; 5F FL4 CATHETER

Lot Number 50873346

Device Problem Air Leak (1008)

Patient Problems Respiratory Distress (2045); Dysphasia (2195); Loss of consciousness (2418)

Event Date 06/09/2015

Event Type  Injury  

Event Description

During cardiac catheterization, 5f fl4 catheter was in use.During 3rd image of left-sided arteries, air bubbles appeared in image of the artery.Pt was awake for 1-2 minutes after, then went unconscious for 4-5 minutes.Pt did not lose pulse, did require bag-valve-mask ventilation.Upon awakening, pt was talking, but could not form complete sentences.Ct of the head was negative.Pt regained ability to form sentences later that day.

• Brand Name: IMPULSE FLEXTRUSION SHAFT, ANGIOGRAPHIC CATHETER
• Type of Device: 5F FL4 CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 4905827
• MDR Text Key: 6836971
• Report Number: MW5043944
• Device Sequence Number: 1
• Product Code: DQO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Lot Number: 50873346
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Weight: 69