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 08/01/2023

Event Type  Injury  

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.Csi id: (b)(4).

Event Description

A distal emoblism was observed following treatments in a 90% stenosed 40mm length lesion in the distal superficial femoral artery with a diamondback 360 peripheral orbital atherectomy device.Clinical subject identifier: (b)(6).

Manufacturer Narrative

Additional information: b5.

Event Description

A distal embolism was observed following three low speed, four medium speed, and seven high speed treatments in a 90% stenosed 40mm length lesion in the distal superficial femoral artery with a diamondback 360 peripheral orbital atherectomy device.The patient was stable.

Event Description

Additional information received indicated that the type of embolism was tissue.

• 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 MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17638153
• MDR Text Key: 322134965
• Report Number: 3004742232-2023-00223
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850026568506
• UDI-Public: (01)10850026568506(17)240630(10)436699-1
• 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: Foreign,Study,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2023

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-200SOLID145
• Device Catalogue Number: 7-10057-13
• Device Lot Number: 436699-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2023
• Initial Date FDA Received: 08/28/2023
• Supplement Dates Manufacturer Received: 09/26/2023; 03/24/2024
• Supplement Dates FDA Received: 10/09/2023; 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 87 YR
• Patient Sex: Female