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

Model Number DBP-125MICRO60

Device Problem Noise, Audible (3273)

Patient Problems Bruise/Contusion (1754); Vascular Dissection (3160)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

The reported oad was received for analysis.An initial visual examination of the handle assembly, saline sheath and driveshaft did not reveal any damage.The crown and distal tip bushing were intact and undamaged.Adhered biological material was observed on the driveshaft and crown.Examination of the area of adhered biological material did not reveal any damage which would have contributed to the accumulation.The morphology and root cause of the biological material is unknown, and it could not be determined if it was related to the reported dissection.A guide wire was inserted and passed through the oad with no resistance.The device was tested on all three speeds and was found to function as intended with no anomalies or unusual noises noted.At the conclusion of the device analysis investigation, the reports of dissection and an unusual noise were unable to be confirmed through analysis.The device history record for this oad lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements prior to distribution.Csi id: (b)(4).

Event Description

During a peripheral atherectomy procedure using a csi diamondback orbital atherectomy device (oad), a dissection occurred.During atherectomy treatment, the device made an unusual noise.Following removal of the oad, a dissection was noted in the area of the sheath.A balloon was inflated at the site of the dissection for three minutes to resolve it and the patient was in stable condition.Per the physician, the cause of the dissection was unknown.The patient presented with bruising the day following the procedure.No additional patient complications have been reported.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6512691600
• MDR Report Key: 8475233
• MDR Text Key: 140676361
• Report Number: 3004742232-2019-00093
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005206
• UDI-Public: (01)10852528005206(17)200229(10)216293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: DBP-125MICRO60
• Device Catalogue Number: DBP-125MICRO60
• Device Lot Number: 216293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2018
• 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
• Patient Outcome(s): Required Intervention