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

Model Number DBP-CART-125MIC145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 05/08/2020

Event Type  Injury  

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 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.

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).

Manufacturer Narrative

Corrected data: b4 (initial report had incorrect date.).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, EXCHANGEABLE
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10121072
• MDR Text Key: 194108057
• Report Number: 3004742232-2020-00159
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005923
• UDI-Public: (01)10852528005923(17)210630(10)274880
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• 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: 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
• Date Manufacturer Received: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 50 YR