MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. VIPERWIRE ADVANCE 335CM ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Catalog Number 37124

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2023

Event Type  malfunction  

Event Description

Distal end of viperwire broke and retained in patient.

• Brand Name: VIPERWIRE ADVANCE 335CM ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.
• MDR Report Key: 18064901
• MDR Text Key: 327593592
• Report Number: MW5147699
• Device Sequence Number: 1
• Product Code: MCW
• 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: 10/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 37124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White