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

Model Number DBP-200SOLID145

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

Patient Problem Embolism/Embolus (4438)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

Investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for user manual states that an embolism 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).

Event Description

A distal embolism of plaque was observed following two low speed, three medium speed, and four high speed treatments in a 90% stenosed, 5.5mm lesion in the distal superficial femoral artery (sfa) with a diamondback 360 peripheral orbital atherectomy device.An anticoagulant medication was administered, flow was improved, and good flow was established.Angioplasty was performed to complete the procedure.The patient was stable.Additional information received on 2/14/2024 indicated there were no procedural complications.No adverse event occurred or allegations of malfunction against the csi device.Additional information received on 3/07/2024 found the embolism was possibly related to the oad.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul 55112
• Manufacturer Contact: poonoy chanthavongsa ; 1225 old hwy 8 nw; st. paul 55112
• MDR Report Key: 18960992
• MDR Text Key: 338379324
• Report Number: 3004742232-2024-00130
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850026568506
• UDI-Public: (01)10850026568506(17)240630(10)436646-1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-13
• Device Lot Number: 436646-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Date Device Manufactured: 06/01/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 41 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian