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

Model Number VPR-GW-FT14

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 05/07/2018

Event Type  malfunction  

Event Description

During procedure, a viper wire flex tip wire was instilled into artery.During advancement of wire and attempting to move wire further in leg, the distal shaft of wire broke off, in patients leg.Under direct flouro, doctor removed portion of wire from the patient leg, using an insufflation balloon.The wire was collected.

• Brand Name: VIPERWIRE ADVANCE FLEXTIP
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 7556504
• MDR Text Key: 109645322
• Report Number: 7556504
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 165611
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 109