MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. (ABBOTT) DIAMONDBACK CORONARY; CORONARY ATHERECTOMY DEVICE

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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.H6 investigation conclusion code 22: the diamondback 360® coronary orbital atherectomy system instructions for use manual states that perforation of vessels is a potential adverse event that may occur and/or require intervention with use of the system.Csi id: (b)(4).
Event or Problem Description
A diamondback 360 coronary orbital atherectomy device (oad) was used for treatment of medium-to-heavily calcified, 85% stenosed, 3.0mm-diameter lesion in circumflex artery (cfx) via femoral access.The oad was advanced to the lesion without any issues.Three low-speed treatments for 25 seconds or less each were performed.A test of contrast was taken, and no issues were found.After the third run, the oad was removed.Image was taken which showed a small perforation.An abbott teleport microcatheter was quickly loaded over the viperwire guide wire.The viperwire was exchanged with non-csi/non-abbott guide wire for more support and used to deploy a 3.0mm abbott trek balloon.The teleport was removed.The 3.0mm abbott trek balloon was used to tamponade the perforation.A 35 x 20 non-abbott stent placement was also performed to resolve the perforation.Post dilation with 3.25 x 8mm abbott nc trek neo coronary dilatation catheter followed.An echocardiogram was taken to ensure there was no significant bleeding around the heart.Abbott perclose proglide suture-mediated closure system was used to close the access site.In the opinion of the physician, there must have been a short kink in the vessel that they did not appreciate; the oad possibly contributed to perforation.The patient was stable but admitted in critical care unit for overnight observation.The patient was moved to basic telemetry on (b)(6)2024 prior to being discharged on (b)(6)2024.The patient was doing very well when discharged.

• Brand Name: DIAMONDBACK CORONARY
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 20525791
• Report Number: 3004742232-2024-00356
• Device Sequence Number: 15725325
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)241031(10)457779-1
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 457779-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown