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

Model Number PRD-SC30-200

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  Injury  

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

A stealth peripheral orbital atherectomy device (oad) was selected for treatment of a profusely diseased superficial femoral artery (sfa), with a calcified bypass graft anastomosis in the distal section of the sfa.The vessel was tortuous, 5mm in length, severely calcified and had multiple 99% focal lesions.The oad was advanced across the sfa but was unable to cross the distal end of the anastomosis section, and it was determined that the oad would not advance through the tortuous anatomy.The procedure was aborted, and as of (b)(6) 2020 there was no follow-up procedure planned.There were no patient injuries.

Manufacturer Narrative

The reported oad was received at csi for analysis.Visual examination identified minor device damage hypothesized to be the result of shipping or handling damage unrelated to the reported event.When tested for functionality, the oad spun as intended, and all expected leds were visibly lit as expected.The oad crown was measured and found to be within specification.At the conclusion of the device analysis investigation, the report could not be confirmed.There was no other damage observed that would have contributed to the reported event.Csi id: (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
• MDR Report Key: 10339739
• MDR Text Key: 200857953
• Report Number: 3004742232-2020-00218
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491295
• UDI-Public: (01)10850000491295(17)220131(10)308489
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• 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: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PRD-SC30-200
• Device Catalogue Number: 7-10059-04
• Device Lot Number: 308489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR