MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360; CATHETER, CORONARY, ATHERECTOMY

Lot Number 169901

Device Problems Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem Vascular Dissection (3160)

Event Date 12/12/2016

Event Type  malfunction  

Event Description

Context was a right superficial femoral artery (sfa) dissection post-atherectomy.Diagnostic run off was performed and the doctor proceeded with the intervention of the right sfa.A csi 2.0 diamondback was used.As the doctor was trying to remove the device, he felt some resistance.He was finally able to remove the device and the wire.He took a picture and realized there was a dissection with no distal flow.He tried to get a wire down to balloon but was unable to advance anything.He took several angiograms of the distal flow and there was no flow.He tried to use a doppler to get distal pulses in the right foot and they were absent.The doctor decided at that point to take the patient to the o.R.The patient was transported to pre op.

• Brand Name: DIAMONDBACK 360
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 14740 kirby dr.; houston TX 77047
• MDR Report Key: 6435396
• MDR Text Key: 70880877
• Report Number: 6435396
• Device Sequence Number: 1
• Product Code: MCX
• 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: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Lot Number: 169901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2017
• 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: 72 YR