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

Model Number 2200-3010

Device Problem Difficult to Remove (1528)

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

Event Date 10/20/2022

Event Type  malfunction  

Event Description

Device failure.Angiosculpt ptca (percutaneous transluminal coronary angioplasty) balloon inserted.Device failed and had difficulty removing from body.X-ray confirmation that whole device removed, and device was saved for further inspection.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• MDR Report Key: 15843405
• MDR Text Key: 304123544
• Report Number: 15843405
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2022,11/01/2022

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 Model Number: 2200-3010
• Device Catalogue Number: 2200-3010
• Device Lot Number: G21030080
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/07/2022
• Date Report to Manufacturer: 11/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30295 DA
• Patient Sex: Male