MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE); CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.Csi id:(b)(4).

Event Description

The glideassist function of the diamondback coronary orbital atherectomy device (oad) was used during repositioning of the viperwire guide wire.The driveshaft of the oad came into contact with the spring tip of the guide wire, and the tip of the wire fractured.The tip of the wire was lodged in the oad driveshaft and was removed when the oad was removed.Since the treatment that had been performed prior to the issue was considered sufficient, the procedure was completed with angioplasty and stent placement.The procedure result was good.

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 11094652
• MDR Text Key: 224595928
• Report Number: 3004742232-2020-00397
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

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 Operator: Health Professional
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1