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

Model Number DBEC-125

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Extravasation (1842); Perforation (2001)

Event Date 10/06/2014

Event Type  Death  

Event Description

It was reported that during a coronary orbital atherectomy procedure, the patient experienced a perforation and later expired.The target lesion was located in the diagonal branch artery.The physician used a 6fr guide catheter, 0.014" 300cm terumo guidewire and a 0.014" quickcross catheter to access the lesion.The terumo guidewire was exchanged for a csi coronary viperwire guidewire and a csi orbital atherectomy device (oad) was loaded onto the guidewire.The physician completed one run at low speed for 15 seconds.Angiography post-oad revealed a perforation in the mid-diagonal artery.A sprinter balloon was advanced to the site of the perforation and inflated for ten minutes at eight atmospheres.Post-balloon inflation angiography revealed that the perforation had been contained; however, extravasation was noted into the pericardium and the patient was hemodynamically unstable.The balloon was again deployed across the perforation and a 2.8mmx16mm covered stent was then deployed across the perforation.Repeat angiography revealed no further extravasation; however, the patient remained hemodynamically unstable.The patient was transferred to the operating room for open pericardial drainage.The patient status continued to decline and expired in the operating room.

Manufacturer Narrative

Device analysis: the oad was returned without the original guide wire.The initial visual and tactile examination of the handle assembly, saline sheath and driveshaft did not reveal any damage or abnormalities.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown.Visual examination of the crown and driveshaft in this area did not reveal any damage that would have contributed to the biological material accumulation.The crown dimensions and crown location on the driveshaft were measured and met the drawing specifications.The driveshaft and saline sheaths were measured and met their respective drawing specifications.An in-house 0.012" test wire was loaded through the device without resistance.When tested, the device spun at low and at high speed with no abnormalities observed.The device functioned as intended.At the conclusion of the failure analysis investigation, the root cause of the perforation and subsequent death could not be determined.The device was within specification and performed as intended.The device history record for this oad 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).

• 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: 4226328
• MDR Text Key: 4971111
• Report Number: 3004742232-2014-00053
• 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: 10/28/2014

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: 09/30/2016
• Device Model Number: DBEC-125
• Device Catalogue Number: DBEC-125
• Device Lot Number: 109374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2014
• Initial Date FDA Received: 11/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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): Death
• Patient Age: 81 YR