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

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

The hospital facility is currently retaining the reported guide wire.If the wire is returned to csi, an analysis will be performed and a supplemental report will be submitted.The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.(b)(4).

Event Description

The target lesion was 99% stenosed and located in the mid to distal circumflex artery.The lesion was primary wired with a non-csi guide wire, following which an attempt was made to insert a second wire.Due to the narrow vessel anatomy, the second wire would not pass and the primary wire was exchanged for viperwire guide wire.The lesion was treated with three passes of the coronary orbital atherectomy device (oad) at low speed and three passes at high speed in a proximal to distal direction.When an attempt was made to insert a balloon, the viperwire guide wire was noted to be fractured.Multiple attempts were made to remove the wire fragment, however they were unsuccessful.The patient then underwent bypass surgery, during which the wire fragment was removed.It was reported to csi that the patient expired due to post-bypass complications unrelated to the guide wire fracture which resulted in multi-system failure.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 9535906
• MDR Text Key: 173675410
• Report Number: 3004742232-2019-00342
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005701
• UDI-Public: (01)10852528005701(17)210131(10)257540
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• 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: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: 257540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/31/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 69