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

Model Number	GWC-12325LG-FLP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/14/2020
Type of Reportable Event	Serious Injury
Additional 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.Additional information regarding the device return has been requested but has not been received.If the device is returned for investigation a supplemental report will be submitted.This event occurred in the same event as oad event reported under mdr 3004742232-2020-00233.(b)(4).
Event or Problem Description
A viperwire guide wire was selected for use during treatment of two heavily calcified lesions in the left circumflex artery.The lesions were separated by an s-curve segment.Treatment of the first lesion was successfully performed.During treatment of the second lesion, the oad nose length fractured.During attempts to remove the fragment, the viperwire was pulled back with the fragment engaged at the end of the wire.The wire fractured.A 3cm segment of the wire was abandoned in vivo.An impella device was placed and the patient was sent to the intensive care unit.As of (b)(6) 2020 the patient was in stable condition.As of (b)(6) 2020 there is no plan to remove the fragments.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10389096
• Report Number: 3004742232-2020-00234
• Device Sequence Number: 1896313
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)210430(10)11100502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 11100502
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 09/21/2020; 08/04/2021
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 10/20/2020; 08/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 79 YR
• Patient Weight: 133