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

Model Number DBP-125MICRO145

Device Problem Infusion or Flow Problem (2964)

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

Event Date 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Failure analysis conclusion: the saline line was not returned for analysis.Fluid was run through the oad and observed flowing out the distal end of the saline sheath as intended.When tested the oad functioned as intended.At the conclusion of the failure analysis investigation, the flushing event could not be not confirmed through analysis.(b)(4).

Event Description

Difficulty was encountered during attempted flushing of the diamondback peripheral orbital atherectomy device (oad).Resistance was encountered during attempts to flush air from the saline tubing.Despite troubleshooting, air could not be purged from the tubing, and a second oad was used to successfully continue the procedure.The patient was well following the procedure.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 8718285
• MDR Text Key: 161506502
• Report Number: 3004742232-2019-00158
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210331(10)261538
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 261538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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