MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number GWC-12325LG-FT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/09/2020

Event Type  malfunction  

Event Description

An atherectomy was performed on patient.Device was removed and left heart catheterization/ percutaneous coronary intervention was completed successfully.Right femoral angiogram was done and a portion of a wire (which was found to be the csi wire) was seen in the right femoral artery.A snare was used to retrieve the wire, which was done successfully.The patient tolerated the procedure well.Manufacturer response for catheter, coronary, atherectomy, diamondback coronary (per site reporter).Manager of cath lab services reported to med rep/ company.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 9933729
• MDR Text Key: 186772527
• Report Number: 9933729
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 30852528005705
• UDI-Public: (01)30852528005705(17)211031(10)295971
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2020

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
• Device Lot Number: 295971
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Weight: 80