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

Model Number DBEC-125

Device Problem Insufficient Information (3190)

Patient Problem Perforation of Vessels (2135)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is unclear how the device may have been involved in the reported perforation.The device was not used in the area of treatment.Although the device became entrapped at one point, it did not interact with the injured vasculature.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.(b)(4).

Event Description

Two treatments on low speed and one treatment on high speed were performed with a diamondback coronary orbital atherectomy device (oad).The target lesion was in the left anterior descending artery distal to the diagonal bifurcation.Imaging quality was poor due to patient size.The lad had a heavily calcified eccentric 80% stenosis at the takeoff of the diagonal branch.The device stalled during treatment and became stuck in the lad.Glideassist did not help to free the oad.After some additional maneuvering, the oad was removed, and the crown was free of tissue.There was a perforation observed in the diagonal branch; the perforation was 5mm or more.The diagonal branch was not wired, and no treatment had been performed there.The physician had not noticed any resistance and had not needed to apply any pressure to treat the lad.Angioplasty was used to seal the perforation, and the patient became agitated.The patient was intubated.Repeat angiography was performed and showed the perforation had been sealed.The procedure was completed with stent placement.The patient was discharged the following day.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13011586
• MDR Text Key: 282284505
• Report Number: 3004742232-2021-00419
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)230831(10)397126-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2021

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: 08/31/2023
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 397126-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Race: White