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

Model Number	DBP-EX-150SOL145
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Hematoma (1884); Perforation of Vessels (2135)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The target area of treatment was the superficial femoral artery.It was difficult to advance the diamondback exchangeable peripheral orbital atherectomy device (oad) through the anterior tibial (at) artery that was heavily calcified, about 3 mm in length and 90%-95% occluded.The physician attempted to treat in the at and popliteal artery.When spinning the oad in the at, the device speed dropped and eventually the oad stopped spinning.The led lights on the oad remained illuminated.It was believed the oad stopped spinning due to the heavy calcification in the at.The oad was removed without any complications.Angiography was checked and perforation was observed in the at.Angioplasty was performed to treat the perforation.The same oad was advanced and was able to cross the at to treat the sfa without issue.The physician wrapped the patient's leg to treat the hematoma that occurred in the mid shin region.In the physician's opinion, the oad caused the perforation and there was no crown jumping observed.As per the physician, the cause of the hematoma was from the orbital atherectomy system interaction with the lesion.The patient was hospitalized and was in observation.The patient was in stable condition.
Additional Manufacturer Narrative
H6 investigation conclusion code 22: the diamondback 360 coronary orbital atherectomy system instructions for use manual states that perforation is a potential adverse event that may occur and/or require intervention with use of the system.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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 19568319
• Report Number: 3004742232-2024-00220
• Device Sequence Number: 6974422
• Product Code: MCW
• UDI-Device Identifier: 10852528005831
• UDI-Public: (01)10852528005831(17)251130(10)515988
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• 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): 06/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: DBP-EX-150SOL145
• Device Catalogue Number: 7-10030-03
• Device Lot Number: 515988
• 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: 05/23/2024
• Initial Report FDA Received Date: 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• 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: Other; Hospitalization
• Patient Sex: Unknown