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

Model Number DBP-125SOLID145

Device Problem Entrapment of Device (1212)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Perforation of Vessels (2135); Vascular System (Circulation), Impaired (2572)

Event Date 04/06/2020

Event Type  Injury  

Manufacturer Narrative

The reported oad and the viperwire guide wire used in the procedure were received at csi for analysis.The guide wire was engaged in the oad, and was removed with some resistance.When re-inserted, the wire would not pass an area of significant adhered biological material observed on the driveshaft and crown.Although the root cause of the accumulating tissue is unknown, it is hypothesized that the crown spun and became stuck in the vessel after seizing due to the biological material accumulation.The report of a perforation could not be confirmed through analysis.When tested, the oad was found to function as intended at all three speeds.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 prior to distribution.Csi id: (b)(4).

Event Description

During treatment, the diamondback peripheral orbital atherectomy device (oad) became stuck in the peroneal.The oad was stopped, re-started and gently pulled back until it dislodged.The oad was then able to be removed from the patient.A perforation with extravasation occurred, and balloon inflation was performed.The vessel did not remain patent following removal of the balloon, however another vessel was opened to supply in-line flow to the foot.The patient was in stable condition following the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn, mn
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, mn ; 2591600
• MDR Report Key: 10001006
• MDR Text Key: 191700936
• Report Number: 3004742232-2020-00131
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)201031(10)243877
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 243877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• 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: 73 YR
• Patient Weight: 55