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

Model Number VPR-GW-14

Device Problem Material Separation (1562)

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

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

The reported oad was returned for analysis with the guide wire utilized during the procedure engaged in the device.Resistance was felt when removing the guide wire from the driveshaft, and a fragment of fractured spring tip coil was found inside the driveshaft.Scanning electron microscopy was performed and identified the particles of radiopaque material inside the oad tip bushing, indicating that the oad was operated over the guide wire spring tip.Additionally, rotational marks and severe mechanical damage to the solder bond were noted, which exceeded the damage typically observed after a driveshaft is operated over a guide wire spring tip.It is possible that the spinning driveshaft made contact with the guide wire spring tip and continued to spin while making contact multiple times, however this could not be confirmed.At the conclusion of the device analysis investigation, the reported event of the device becoming stuck on the guide wire was confirmed.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.Csi id# (b)(4).

Event Description

Following peripheral atherectomy treatment using a csi orbital atherectomy device (oad), the device was unable to be removed and was found to be stuck on the guide wire.The device and wire were removed together, the lesion was re-wired, and the procedure was completed with balloon angioplasty.No patient complications were reported.Upon analysis of the oad and guide wire, a fragment of the guide wire spring tip was found to be fractured and detached.

• 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: 8056326
• MDR Text Key: 127866133
• Report Number: 3004742232-2018-00334
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151260
• 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: 11/09/2018

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 Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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