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

Model Number DBP-EX-125SOL145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/18/2023

Event Type  Injury  

Event Description

Following one low-speed and one high-speed treatment of a 90% stenosed, moderately calcified lesion in the anterior tibial (at) artery using the diamondback 360 exchangeable peripheral orbital atherectomy device (oad) via femoral antegrade access, angiographic imaging revealed no flow and embolism.The entire vessel into the foot shut down.Balloon angioplasty did not restore flow.The patient was admitted to intensive care unit (icu) and anti-coagulant and blood thinners were administered overnight.

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® peripheral orbital atherectomy system instructions for user manual states that slow flow and embolism are potential adverse events that may occur and/or require intervention with use of the system.H6 health effect - clinical code 4581: slow/no flow.Csi id: (b)(4).

Manufacturer Narrative

Csi id: (b)(4).

Event Description

Additional information was received.According to the physician, there was no pre-existing thrombus.The patient was in stable condition and discharged.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL 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: 18119218
• MDR Text Key: 327924952
• Report Number: 3004742232-2023-00259
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005824
• UDI-Public: (01)10852528005824(17)250430(10)485422
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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,Followup
• Report Date: 12/07/2023

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 Model Number: DBP-EX-125SOL145
• Device Lot Number: 485422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/13/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2023
• 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; Hospitalization