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

Model Number 210-153-5UU

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Perforation of Vessels (2135); Device Embedded In Tissue or Plaque (3165)

Event Date 04/28/2021

Event Type  Injury  

Event Description

Perforation of lva after stent placement, balloon inserted for perforation.Tip of balloon broke off still located in the lva.Fda safety report id# (b)(4).

• Brand Name: SAPPHIRE II PRO
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): ORBUSNEICH MEDICAL TRADING, INC.
• MDR Report Key: 11760107
• MDR Text Key: 248798167
• Report Number: MW5101105
• Device Sequence Number: 1
• Product Code: LOX
• 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: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Model Number: 210-153-5UU
• Device Lot Number: 4203582002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 83 YR