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

Model Number	DBEC-125
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	04/18/2024
Type of Reportable Event	Death
Event or Problem Description
A diamondback 360 coronary orbital atherectomy device (oad) was used to treat 95% stenosed, heavily calcified, 3.5mm proximal left anterior descending artery.Three low-speed treatments were performed with injections in between each treatment.After successful treatment, the oad was removed, however, the viperwire advance guide wire was pulled during the removal of the oad and the wire position was lost.The oad and viperwire were removed together.The vessel was re-wired with a non-csi guide wire.A perforation was observed on fluoroscopy.Multiple balloons and stents were used in an attempt to treat the perforation.The patient's activated clotting time was over 600 seconds.Pericardiocentesis was performed and an echocardiogram was used.Hematoma developed.The patient coded and expired.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted once the investigation is complete.Csi id: (b)(4).
Additional Manufacturer Narrative
H6: 1884 no longer applies to this event, as the bleed was observed at the access site and not related to orbital atherectomy.The oad was returned for analysis.There was no damage observed with the driveshaft or handle assembly that would have contributed to the reported event.Review of the device data log did not identify any events that would have contributed to the reported complaint.The oad crown diameter was measured and met drawing specifications.However, analysis did observe adhered biological material on the driveshaft at the crown section.It is unknown whether the accumulated material was related to the reported complaint.A test wire was able to pass the adhered material with some resistance.Analysis did not identify any damage that may have contributed to the accumulating material.The morphology and exact root cause of the accumulated biological material was unknown.When tested, the oad functioned 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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: 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: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19330800
• Report Number: 3004742232-2024-00190
• Device Sequence Number: 6942456
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)240430(10)428934-1
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 04/30/2024
• Device Model Number: DBEC-125
• Device Catalogue Number: 7-10060-09
• Device Lot Number: 428934-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2022
• 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: Death; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 86 KG