MAUDE Adverse Event Report: SAPPHIRE; SAPPHIRE NC PLUS

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Extravasation (1842); Perforation (2001)

Event Date 03/12/2021

Event Type  Injury  

Event Description

A sapphire balloon was used in the left main (lm) and proximal circumflex (cx) artery as well as with an obtuse marginal lesion following eight atherectomy treatments on low speed.Angiography was performed after atherectomy, and no issues were noticed.Angioplasty and stent placement were performed in the om and cx.Following the second post dilation in the cx with the sapphire balloon, extravasation was noted in the area of the stent.A second balloon was used for tamponade, but the patient responded poorly.A second stent was deployed within the first stent to cover the perforation.The patient then became hemodynamically stable and was eventually transported to the cardiac care unit in stable condition.The procedure was delayed by 30 minutes or more.The patient received additional pressors, and extra saline.The physician stated the sapphire nc plus caused the perforation and that the balloon was too stiff.The physician stated csi's oad did not play a role in the perforation.

• Brand Name: SAPPHIRE
• Type of Device: SAPPHIRE NC PLUS
• MDR Report Key: 11490951
• MDR Text Key: 240744296
• Report Number: 3014148220-2021-00691
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2021
• Event Location: Hospital
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization