MAUDE Adverse Event Report: ORBUSNEICH MEDICAL, INC. SAPPHIRE PTCA; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Lot Number 4258931808

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Event Description

Performed coronary angioplasty without issue.Removed balloon from coronary and from sheath without incident, then attempted to remove balloon from wire.The balloon was stuck to wire and when attempted to remove the balloon, it fractured.

• Brand Name: SAPPHIRE PTCA
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ORBUSNEICH MEDICAL, INC.; 5363 nw 35th ave; fort lauderdale FL 33309
• MDR Report Key: 9426198
• MDR Text Key: 169514234
• Report Number: 9426198
• Device Sequence Number: 1
• Product Code: LOX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 4258931808
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA