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

Model Number DBP-EX-125MIC145

Device Problem Entrapment of Device (1212)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/27/2022

Event Type  Injury  

Manufacturer Narrative

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.Review of imaging following the procedure revealed that the vessel spasm likely occurred due to the oad being in the tight artery.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.(b)(4).Csi id: (b)(4).

Event Description

The diamondback exchangeable orbital atherectomy system (oad) was selected for treatment of a patient who had pre-existing no flow in the anterior tibial artery and was experiencing pain.The oad was operated in the at artery on low and medium speed without issue and then advanced to the mid at, however the device sounded as though it were wrapped around tissue.The control knob was locked and the crown was retracted, however the crown would not move as it was stuck in the vessel and the patient experienced pain.Nitroglycerin and verapamil were administered to loosen the vessel, due to a spasm that had occurred, however this was unsuccessful.Due to the size of the sheath, balloons and guide catheters could not be advanced over the crown.The oad was manually tugged, but the crown remained stuck.Glideassist mode was activated and the crown moved a few inches, but then stopped and the patient experienced additional pain.During attempts to remove the oad, the oad became stretched.The driveshaft was cut and removed from the saline sheath.The catheter was still in place with the crown in the proximal at.A catheter was advanced and placed by the crown.Pulling and manipulation of the crown were performed, and the patient experienced hypotension and pain.The crown remained stuck.The catheter was pulled harder, and was removed, however the crown detached and remained in vivo.An angiogram revealed the at was shut down, however this was likely a pre-existing condition prior to the procedure.Balloon angioplasty was performed to the posterior tibial artery.Following the procedure the patient had pain unrelated to the oad and a week following the procedure the patient was doing well.

• 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: brittany leider ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512591600
• MDR Report Key: 13533855
• MDR Text Key: 285608547
• Report Number: 3004742232-2022-00039
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)231130(10)411330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-EX-125MIC145
• Device Catalogue Number: 7-10030-01
• Device Lot Number: 411330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White