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

Model Number DBP-125MICRO145

Device Problem Entrapment of Device (1212)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); No Code Available (3191)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.It was reported to csi that the reported device will be retained by the site indefinitely.If the device is returned to csi, an analysis will be performed and a supplemental report will be submitted.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), the device became stuck in the patient and surgical removal was required.Following successful treatment of a lesion in the anterior tibial artery (at), the oad was advanced to treat a second lesion in the dorsalis pedis artery.During treatment of this lesion, no abnormal sound was heard which would indicate the device had become stuck, however resistance was felt during the treatment.It was reported that the physician pushed forward through the resistance instead of stopping treatment per the product instructions for use (ifu) warning.When treatment was completed and the device was pulled back for removal, the control knob pulled forward and the device was unable to be removed.It was suspected that the control knob may not have been locked prior to device removal, however this could not be confirmed.Nitroglycerin was administered, however due to the low blood pressure of the patient it was discontinued.Multiple attempts were made to resolve the issue.The device was pulled in attempt to remove it, however the patient presented with groin pain.The oad driveshaft was cut in an attempt to advance the shaft over the crown to dislodge it, however due to vessel spasm the shaft would not advance.An ambulance was called and the patient was transferred to a hospital where they underwent cut down surgery to remove the device.The patient was discharged in stable condition following the surgical procedure.

• 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; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 8396796
• MDR Text Key: 138072985
• Report Number: 3004742232-2019-00070
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)200831(10)238349
• 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: 03/06/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 238349
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 50 YR