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

Model Number PRD-SC30-125

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2018

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.During preparation for the procedure, it was noted that the saline solution would not advance through the tubing of the peripheral device.The procedure was completed with balloon angioplasty and there were no adverse consequences to the patient.

Manufacturer Narrative

The reported oad was received for analysis.When the device was tested for functionality, there was no fluid flow observed through the saline line.Examination of the saline line revealed an adhesive occlusion in the saline hose barb connector on the hose junction.There were no other issues observed with the device.At the conclusion of the device analysis investigation, the reported event 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.(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: 7973603
• MDR Text Key: 123961111
• Report Number: 3004742232-2018-00308
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005039
• UDI-Public: (01)10852528005039(17)191031(10)173425
• Combination Product (y/n): N
• PMA/PMN Number: K110389
• 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: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2019
• Device Model Number: PRD-SC30-125
• Device Catalogue Number: 70056-03
• Device Lot Number: 173425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2018
• Date Manufacturer Received: 10/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly
• Patient Age: 73 YR