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

Model Number DBEC-125

Device Problems Positioning Failure (1158); Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

The diamondback coronary orbital atherectomy device (oad) became stuck on the wire during testing.The device and wire were removed from the patient together.Gaining wire access to the right coronary artery had been difficult, and the physician was unable to re-wire the vessel after removal of the oad and guide wire.The procedure was aborted due to contrast and radiation exposure concerns.

Manufacturer Narrative

Failure analysis conclusion: analysis revealed the oad and guide wire were not compatible due to user error; the issue occurred because the wrong guide wire was used.The returned guide wire was a peripheral viper wire flextip gen 2.The required coronary guide wire model is indicated for use with the coronary oad and is smaller in diameter than the peripheral guidewire.At the conclusion of the failure analysis investigation the reported event was confirmed.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8544273
• MDR Text Key: 142930665
• Report Number: 3004742232-2019-00116
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005428
• UDI-Public: (01)10852528005428(17)210131(10)253093
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-12
• Device Lot Number: 253093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 59