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

Model Number VPR-GW-14

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  Injury  

Manufacturer Narrative

The reported guide wire was received for analysis.A bend in the guide wire core shaft was observed.The root cause of the bend was unable to be determined.There was no additional damage observed.At the conclusion of the device analysis, the reported event was confirmed.The material inspection report for this guide wire 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

A viperwire guide wire was selected for use with an orbital atherectomy device (oad) for treatment of moderately calcified, 80% stenosed lesion in the mid anterior tibial artery.Orbital atherectomy was successfully completed, and the viperwire was observed to be bent at the distal end.The oad was removed and an attempt was made to remove the viperwire.A new, longer catheter was opened to remove the viperwire.The procedure was completed successfully with no patient complications.

• 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: sarah hicks ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 11395218
• MDR Text Key: 234225477
• Report Number: 3004742232-2021-00065
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005077
• UDI-Public: (01)10852528005077(17)220831(10)343954
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: VPR-GW-14
• Device Catalogue Number: 72023-01
• Device Lot Number: 343954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2020
• 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: 66 YR
• Patient Weight: 50