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

Model Number DBP-125SOLID145

Device Problems Entrapment of Device (1212); Unintended System Motion (1430)

Patient Problem Vascular Dissection (3160)

Event Date 04/12/2018

Event Type  Injury  

Manufacturer Narrative

The reported orbital atherectomy device (oad) was returned with the guide wire engaged and stuck in the device.Detailed analysis revealed adhered and embedded biological material on the driveshaft and on the guide wire which prevented removal of the guide wire from the device.There was no damage observed with the device or the guide wire that would have contributed to the reported event.When tested the device spun during all three speeds and functioned with no abnormalities observed.The morphology of the biological material is not known and the exact root cause of accumulating tissue remains unknown.Examination in the areas of the adhered tissue did not reveal any damage that would have contributed to the accumulation.At the conclusion of the device analysis investigation, the reported event of the oad becoming stuck on the guide wire was confirmed.However, the root cause of the device becoming stuck on the guide wire, crown jumping, and dissection could not be conclusively determined.(b)(4).

Event Description

During an atherectomy procedure using a csi peripheral orbital atherectomy device (oad), a dissection occurred.The target lesion was in the tibial-peroneal trunk (tpt) artery.The crown of the device was noted to jump back at the completion of the passes through the lesion.Upon removal of the device, it was noted to be stuck on the guide wire.The device and the wire were removed together and a dissection was noted to have occurred.The dissection was treated with the placement of a stent.The patient was reported to be in stable condition after the procedure and no further patient complications have been reported as a result of this event.

• 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: alyssa ikeri ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 7487836
• MDR Text Key: 107382333
• Report Number: 3004742232-2018-00123
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)200131(10)213398
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• 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: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2020
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 213398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2018
• 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: 75 YR
• Patient Weight: 68