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

Model Number DBP-125MICRO145

Device Problem Entrapment of Device (1212)

Patient Problem Vascular Dissection (3160)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

The reported oad and guide wire were received for analysis.The oad and guide wire were engaged, and resistance was felt in the area of the oad crown when removing the guide wire from the oad.Adhered biological material was observed on the oad crown.Examination of the area of adhered material did not reveal any damage that would have contributed to the accumulation.The morphology and exact root cause of the accumulating material is unknown.Examination of the driveshaft revealed some adhered material embedded within the driveshaft filars.Suspected shipping damaged was removed, and the guide wire was able to be advanced through the oad, including the area of adhered material.The oad was tested, spun at all speeds, and functioned as intended.At the conclusion of device analysis, the reported event of the device being stuck on the wire was confirmed.The reported dissection was unable to be confirmed through analysis.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 material inspection report for the reported guide wire was unable to be reviewed, as the lot number was not provided.The diamondback peripheral orbital atherectomy device instructions for use states that dissection is a possible adverse event which can occur with use of the diamondback peripheral orbital atherectomy device.(b)(4).

Event Description

During a procedure, the peripheral pluto orbital atherectomy device (oad) became stuck on the guide wire and a dissection occurred.The target, chronic total occluded (cto) lesion was located in the posterior tibial (pt) artery.The lesion was initially wired with a non-csi guide wire, and the wire was exchanged for a viperwire guide wire.Prior to orbital atherectomy treatment, the oad was stuck on the guide wire.The oad and guide wire were removed and the vessel was re-wired.The original oad was re-introduced to the patient over the second guide wire.After treatment, the oad was again stuck on the guide wire.The oad and guide wire were removed together from the patient.Subsequently, a dissection was observed, the vessel was re-wired with a non-csi guide wire, and the dissection was treated with a stent.After stenting, it was noted that the non-csi guide wire and stent were located in the dissection plane and not in the vessel.The opinion of the physician was that the initial non-csi guide wire was subintimal and created an initial minor dissection which was exacerbated when the oad was used to treat the vessel.A distal pt access was obtained to assess the severity of the dissection.It was noted that the patient was fine throughout 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; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 9672482
• MDR Text Key: 183115710
• Report Number: 3004742232-2020-00028
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)211031(10)292437
• 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: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 292437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2019
• 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: 68 YR