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

Model Number DBP-125SOLID145

Device Problem Difficult to Advance (2920)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/15/2018

Event Type  malfunction  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad) a device malfunction occurred leading to a procedural delay.Upon insertion, the peripheral device was difficult advance over the guide wire and required additional time to reach the lesion.The first target lesion was 100% stenosed and was treated with the oad.Following treatment, the device was unable to advance to the next lesion and was difficult to remove from the patient, leading to a procedural delay.The device and wire were removed together and the lesion was re-wired and the oad replaced to complete the procedure with additional atherectomy and balloon angioplasty.

Manufacturer Narrative

The reported oad was received for analysis.A guide wire was advanced through the device and met resistance proximal to the driveshaft tip bushing.Examination of the area revealed embedded biological material within the driveshaft filars.When this area was destructively removed, the guide wire was able to pass through the device with no resistance.The oad was then tested and found to function as intended with no anomalies noted.As the original guide wire utilized during the procedure was not returned for analysis, it could not be determined if it contributed to the reported event.At the conclusion of the device analysis investigation, the reported inability of the device to advance over the guide wire was confirmed to be due to embedded biological material in the driveshaft.However, the source of the biological material was unable to be determined.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.(b)(4).

• 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
• MDR Report Key: 8054716
• MDR Text Key: 126649707
• Report Number: 3004742232-2018-00332
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)200630(10)230615
• Combination Product (y/n): N
• PMA/PMN Number: K133399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 230615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1