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

Model Number	DBP-EX-125MIC145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient received an amputation of the toe following the procedure, but this was unrelated to the events during the procedure and was already planned.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).
Event or Problem Description
The patient presented with a gangrenous wound to the right first toe with dorsalis pedis (dp) and posterior tibial (pt) pulses.Pre-intervention angiogram demonstrated complete pt and peroneal artery runoff.The anterior tibial (at) artery demonstrated appreciably slow flow.Selective angiography revealed a short, distal, total occlusion about 5cm in length, which was reconstituted and fed collaterally by the peroneal artery, ultimately providing dorsalis pedis flow.After an unsuccessful attempt at angioplasty at the focal dp lesion, a diamondback exchangeable series peripheral orbital atherectomy device (oad) was selected for treatment of the distal half of the at.Two treatments were performed on low speed, and one treatment was performed on medium speed.Glideassist was used to remove the oad, and angioplasty was performed.Post interventional angiogram again demonstrated slow flow through the at with only trace perfusion to the foot.The formerly totally occluded segment of vessel which was treated appeared patent and free of dissection.Although no attempt was made to treat them, the pt and peroneal arteries demonstrated very sluggish outflow.The physician believed this was likely due to vessel spasm causing recoil.The physician's opinion was that the flow issue would resolve over time.Intraarterial nitroglycerin was administered.Doppler showed triphasic pulses in the dp & pt.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL 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: 13412245
• Report Number: 3004742232-2022-00024
• Device Sequence Number: 4690550
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)231031(10)405780
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/01/2022

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: 10/31/2023
• Device Model Number: DBP-EX-125MIC145
• Device Catalogue Number: 7-10030-01
• Device Lot Number: 405780
• 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: 01/07/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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
• Patient Sex: Male
• Patient Ethnicity: Hispanic