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

Model Number DBP-125SOLID145

Device Problem Noise, Audible (3273)

Patient Problems Thrombus (2101); Vascular Dissection (3160)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

The reported oad was returned for analysis with the guide wire.Adhered biological material was observed on the distal and proximal edges of the driveshaft crown.The root cause of the tissue accumulation was unable to be determined.The returned guide wire was able to pass through the oad and area of tissue with minimal resistance.The spring tip of the guide were was found to be deformed but intact, and it was unable to be determined if this occurred during the procedure or during removal of the device.When tested, the oad functioned as intended with no anomalies noted.At the conclusion of the device analysis investigation, the reported event was unable to be confirmed.The device history record and material inspection record for the oad and guide wire lot numbers has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The devices met material, assembly, and quality control requirements.(b)(4).

Event Description

During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a dissection occurred.The target lesion was located in the anterior tibial artery and was treated with the oad using two passes on low speed and one pass on medium speed.Following the third pass, the device began to make an abnormal noise and was removed.Tissue wrap was noted on the crown of the oad, and imaging showed a flow limiting dissection and thrombus.Balloon angioplasty was performed for four minutes to resolve the dissection and 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; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 7579765
• MDR Text Key: 110445253
• Report Number: 3004742232-2018-00160
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)200229(10)217084
• 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: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/29/2020
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 217084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2018
• 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: 93