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

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problems ST Segment Elevation (2059); Vascular System (Circulation), Impaired (2572); Device Embedded In Tissue or Plaque (3165)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

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.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.(b)(4).

Event Description

A viperwire guide wire was selected for use in the left anterior descending artery, which was 90% stenotic.An intravascular ultrasound catheter could not be advanced into the lesion, but glideassist was used to advance the orbital atherectomy device (oad) into it.During advancement of the oad, the viperwire retracted, and the oad jumped.The tip of the oad contacted the viperwire spring tip, and the spring tip of the wire fractured.Multiple attempts were made over the course of an hour to retrieve the fragment, but the fragment could not be removed.Treatment was continued in the proximal lesion.The patient experienced st elevations, which the physician attributed to poor distal flow caused by the guide wire fragment.An intra-aortic balloon pump (iabp) was inserted, and attempts to remove the fragment were abandoned.The patient's condition was good, and the iabp was removed the following day.The physician remarked that additional pre-treatment considerations should have been made prior to atherectomy.

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10042750
• MDR Text Key: 190491736
• Report Number: 3004742232-2020-00134
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491141
• UDI-Public: (01)10850000491141(17)210630(10)279639
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: GWC-12325LG-FT
• Device Lot Number: 279639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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): Required Intervention
• Patient Age: 69 YR