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U.S. Department of Health and Human Services

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

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SPECTRANETICS CORP. ANGIOSCULPT PTCA SCORING BALLOON CATHETER; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
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.
 
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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 Key16253799
MDR Text Key308377532
Report NumberMW5114523
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Date04/30/2024
Device Model Number2200-3510
Device Lot NumberG21040088
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/26/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexFemale
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