MAUDE Adverse Event Report: SPECTRANETICS CORP. ANGIOSCULPT PTCA SCORING BALLOON CATHETER; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 2200-3510

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/16/2023

Event Type  malfunction  

Event Description

During a coronary intervention, an angiosculpt ptca scoring balloon was inserted by the cardiologist, through the sheath into the pt's body.Upon insertion the back end of the device (piece with the hub) broke off.The piece that was in the sheath was easily removed.No piece of the device remained in the pt.There was no pt harm.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS CORP.
• MDR Report Key: 16253799
• MDR Text Key: 308377532
• Report Number: MW5114523
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• 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: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 2200-3510
• Device Lot Number: G21040088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female