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

Model Number VPR-GW-14

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

The reported guide wire was returned for analysis with the oad utilized during the procedure.An examination was performed and identified what appeared to be an additional spring tip coil attached to the returned guide wire.The material was analyzed using scanning electron microscopy and was found to have a similar dimensional and material composition as the returned guide wire, and the material of the returned coil and a control coil were found to be the same.Csi's manufacturing vendor for this guide wire has been made aware of this finding.At the conclusion of the device analysis investigation, the reported event was confirmed.The material inspection report for the reported guide wire was unable to be reviewed, as the lot number was not provided.(b)(4).

Event Description

During a peripheral atherectomy procedure using a csi diamondback orbital atherectomy device (oad), metal was found to be wrapped around the guide wire and oad.Following atherectomy treatment of the tibial and superficial femoral arteries, a black spot was noted in the procedure images.When the device and wire were removed from the patient, metal was noted to be wrapped around the device.Upon analysis of the oad and guide wire, the metal fragment was found to be an additional spring tip coil attached to the guide wire.

• 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 ; 6512591600
• MDR Report Key: 8245681
• MDR Text Key: 132991225
• Report Number: 3004742232-2019-00024
• 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: 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2019
• 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: 11/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2018
• 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