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

Model Number DBP-200SOLID145

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

Patient Problems Embolism/Embolus (4438); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  Injury  

Manufacturer Narrative

H6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that distal embolization is a potential adverse event that may occur and/or require intervention with use of the system.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 diamondback 360 peripheral orbital atherectomy device (oad) was used to treat a lesion in the distal superficial femoral artery.A distal embolization was observed after treatment.In the physician's opinion, the distal embolization was due to the orbital atherectomy.Revascularization was performed to resolve the embolization.The patient was stable.

Manufacturer Narrative

Correction: this report is a duplicate of medwatch mfr report # 3004742232-2023-00223, csi id (b)(6).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ORBITAL 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 55112
• MDR Report Key: 18485077
• MDR Text Key: 332564336
• Report Number: 3004742232-2024-00076
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBP-200SOLID145
• Device Lot Number: 436699-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• 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): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Race: Asian