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

Model Number	DBP-CART-125MIC145
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
Vessel spasm was observed on imaging during a procedure in which a diamondback peripheral orbital atherectomy device was used.The spasm resolved without intervention by the conclusion of the procedure.
Additional Manufacturer Narrative
Device analysis conclusion: the cartridge was received without the oad handle for analysis.There was no visible damage on the cartridge.When functionally tested, the cartridge operated as intended.At the conclusion of the failure analysis investigation the reported vessel spasm could not be confirmed.The cause of the reported vessel spasm is unknown.Per the opinion of the physician, the spasm may have been caused by a combination of factors and not just by use of the oad.The diamondback 360® peripheral orbital atherectomy system exchangeable series instructions for use manual states that vessel spasm is a possible adverse event which can occur with use of the system.Csi id: (b)(4).
Additional Manufacturer Narrative
Corrected data: b4 (initial report had incorrect date.).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, EXCHANGEABLE
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10121072
• Report Number: 3004742232-2020-00159
• Device Sequence Number: 2153263
• Product Code: MCW
• UDI-Device Identifier: 10852528005923
• UDI-Public: (01)10852528005923(17)210630(10)274880
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: DBP-CART-125MIC145
• Device Catalogue Number: 7-10031-01
• Device Lot Number: 274880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 05/08/2020; 06/05/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 06/05/2020; 06/18/2020
• 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: Life Threatening; Required Intervention
• Patient Age: 50 YR