MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED VIPER WIRE .014X.014; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number VPR-GW-FLEX14

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Calcium Deposits/Calcification (1758); Perforation (2001); Foreign Body In Patient (2687)

Event Date 09/16/2021

Event Type  Injury  

Event Description

Heavily calcified right sfa.Pt had a right sfa atherectomy angioplasty and stenting.The distal tip of the viper wire had sheared off into the small branch of the geniculate artery.The attempt to snare the wire was not successful.Wire was subsequently advanced into the distal portion of the small branch of the genicular artery.The results have been explained to the patient as well as the family members at great length.He had a distal runoff.With the attempt of the stenting the wire with multiple approaches including the snare, there is an evidence of small branch perforation noted.Pt kept overnight in the icu for monitoring and remained hemodynamically stable; discharged home (b)(6) 2021.Fda safety report id # (b)(4).

• Brand Name: VIPER WIRE .014X.014
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED
• MDR Report Key: 12547365
• MDR Text Key: 274071016
• Report Number: MW5104270
• Device Sequence Number: 1
• Product Code: MCW
• 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: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VPR-GW-FLEX14
• Device Catalogue Number: 7-10041-03
• Device Lot Number: 376123-1
• Was Device Available for Evaluation?: No
• 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): Required Intervention
• Patient Age: 81 YR
• Patient Weight: 82