MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. ORBITAL ATHORECTOMY GUIDEWIRE; VIPER WIRES

Model Number VPR-GW-FT14

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

Patient Problems Pain (1994); Thrombosis (2100)

Event Date 08/25/2017

Event Type  Injury  

Event Description

On (b)(6) 2017: patient underwent arteriogram, orbital atherectomy and balloon angioplasty on right lower extremity and discharged home.On (b)(6) 2017: patient presented to ed with right calf path and discoloration of right foot - patient admitted to hospital.On (b)(6) 2017: patient underwent arteriogram, fluoroscopic guided intra-arterial foreign body retrieval and catheter directed arterial thrombolytic lysis.Foreign body identified as 70cm wire fragment from guidewire.On(b)(6) : patient underwent repeat arteriogram and arterial mechanical thrombectomy.On (b)(6) patient underwent right open 4 compartment release of right lower extremity.On (b)(6) patient underwent us guided vascular access, arteriogram and right groin exploration with thrombectomy followed by bovine batch angioplasty, intrapopliteal artery exploration with below knee thrombectomy, posterior tibial artery exploration at ankle with thrombectomy.On(b)(6) patient remains hospitalized with severe pain to right leg, wound vac in place.

• Brand Name: ORBITAL ATHORECTOMY GUIDEWIRE
• Type of Device: VIPER WIRES
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; st. paul MN 55112
• MDR Report Key: 6914001
• MDR Text Key: 88269897
• Report Number: MW5072597
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 196571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 87