MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM; CORONARY ATHERECTOMY DEVICE

Model Number DBEC-125

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

Patient Problem Great Vessel Perforation (2152)

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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 prior to distribution.Csi id: (b)(4).

Event Description

A diamondback coronary orbital atherectomy device (oad) was used to treat multiple lesion in the right coronary artery (rca).The ostial lesion was treated in a distal to proximal direction with two treatment passes on low speed.The oad was then advanced to the mid lesion, which was treated in a proximal to distal direction with two treatment passes on low speed.The distal rca lesion was then treated in a proximal to distal direction with an additional two treatment passes on low speed.Contrast was injected after each treatment pass.The oad was removed and a balloon was inserted over the viperwire guide wire.When the balloon was advanced to the distal wire location, the wire and balloon became seized due to a piece of calcium which had become lodged in the end of the balloon.Per the opinion of the physician, the balloon may have contacted the vessel wall during advancement, resulting in the calcium and seizure on the guide wire.The balloon and wire were removed, and imaging showed a contained perforation in the vessel.An additional balloon was inflated in the proximal rca to occlude flow during attempts to rewire the lesion, however this was unsuccessful.A catheter was placed and imaging showed mature collateral vessels feeding the rca.An echocardiogram was performed and was normal with no effusion in the pericardium.The blood pressure and electrocardiogram of the patient were stable.The physician determined that the contained perforation would heal and no additional intervention was performed.The patient left the procedure in stable condition, however the patient expired the night of 6 october.Per the opinion of the physician, it could not be determined if the oad or balloon caused the perforation.The primary cause of the patient death was the underlying conditions of the patient which were not properly treated: cancer, copd, and seizures.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 10680291
• MDR Text Key: 211447556
• Report Number: 3004742232-2020-00317
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491356
• UDI-Public: (01)10850000491356(17)220331(10)316363
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/14/2020

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-01
• Device Lot Number: 316363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• 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): Life Threatening
• Patient Age: 79 YR
• Patient Weight: 51