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

Model Number GWC-12325LG-FLP

Device Problem Material Fragmentation (1261)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 07/13/2015

Event Type  Injury  

Manufacturer Narrative

The viperwire guidewire and device were discarded by the facility; therefore, an analysis of the actual complaint devices is not possible.The material inspection record 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 device met material, assembly, and quality control requirements.(b)(4).Discarded by facility.

Event Description

It was reported that during a coronary orbital atherectomy procedure, the tip of a csi coronary guidewire was fractured off and was left in the patient.The target lesion was 99% stenotic, 40mm in length and was located in the left anterior descending (lad) artery.The proximal and mid portions of the lad were severely calcified and had previously been stented.The physician used an 8fr introducer sheath, xb 3.5 guide catheter and a 0.014" fielder xt guidewire to access the lesion.The physician wired the vessel with the fielder xt guidewire and exchanged it for a csi viperwire guidewire.A csi orbital atherectomy device (oad) was loaded onto the guidewire and advanced to the lad.The physician performed three runs at low speed and one run at high speed, but was unable to cross the mid-portion of the lesion.The oad was removed from the patient, but during removal, the viperwire had retracted proximally with the device.While attempting to re-wire the vessel with the viperwire, the tip of the wire fractured off.The physician exchanged the viperwire (without the tip) for a miraclebros12 guidewire and post-dilated the lesion with multiple balloon angioplasty inflations and placement of a stent.A second stent was planned to be deployed in the lad, but while advancing, the stent dislodged from the delivery balloon.It was unable to be snared, so the physician deployed a third stent to pin the dislodged stent and viperwire tip against the vessel wall.Three additional stents were placed in the left main and lad arteries to restore flow to the vessels.The patient status remained stable throughout the procedure.A request for additional information was made, but was denied to due to facility policies.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 5041899
• MDR Text Key: 24601793
• Report Number: 3004742232-2015-00057
• 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
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/31/2016
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: GWC-12325LG-FLP
• Device Lot Number: 10480017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• 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