MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE

Model Number GWC-12325LG-FLP

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problems Calcium Deposits/Calcification (1758); Device Embedded In Tissue or Plaque (3165)

Event Date 06/18/2014

Event Type  Injury  

Event Description

It was reported that during a coronary orbital atherectomy procedure, a csi coronary guidewire fractured and a portion was left in the patient.The target lesion was severely calcified, 15mm in length, and it was located in the proximal-to-mid left anterior descending (lad) artery.The physician used a whisper guidewire to access the lesion.The physician then used a 1.2mm balloon to exchange for the csi viperwire guidewire.He loaded a csi coronary orbital atherectomy device (oad) onto the guidewire and successfully treated the lesion with the device.The physician removed the device and followed up atherectomy with balloon angioplasty and stent placement, which were performed with the csi viperwire in place.As the physician was removing the viperwire, he noticed that the tip of the wire had fractured off and migrated to the distal lad.The physician attempted to snare the wire but was unsuccessful and decided to leave the fractured portion in the patient as there was no harm.There were no patient complications noted during the case and the patient status remained stable.Additional information has been requested, but the facility is unable to release further information per their own internal policies.

Manufacturer Narrative

The device is being retained by the facility; therefore an analysis of the actual complaint device is not possible.The material inspection report for this viperwire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The wire met material, assembly, and quality control requirements.(b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY DIAMONDBACK ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 3931994
• MDR Text Key: 4573133
• Report Number: 3004742232-2014-00033
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2015
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: GWC-12325LG-FLP
• Device Lot Number: 10325233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/14/2014
• 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
• Patient Outcome(s): Other