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

Model Number DBP-200SOLID145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The analysis is in progress.A supplemental report will be submitted when the investigation is complete.Csi id: (b)(4).

Event Description

A diamondback peripheral orbital atherectomy device (oad) was used for treatment of disease in the common femoral artery (cf) and superficial femoral artery (sfa).Treatment was intentionally planned for the distal two thirds of the sfa, where a preexisting stent was implanted.The stented area was diseased throughout with a focal area in the center.The stents appeared to be 6.0mm in diameter, and a 2.0mm crown was used.The treatment area appeared to be about 300mm in length.One treatment pass each was performed on low and medium speeds followed by two high speed treatments in the distal half of the target area.The same sequence was repeated for the proximal half of the stent.Appropriate rest times were observed between treatments.Treatment was then performed in the cf through the proximal sfa where no preexisting stent was.Imaging thereafter revealed slow flow through the vessel.A drug coated balloon was used to treat the cf through proximal sfa.Treatment was successful.Imaging thereafter revealed no flow in the proximal sfa and distal.A catheter was advanced into the vessel, and the distal popliteal appeared to be blocked.The blockage appeared to be thrombus.When the oad was removed, tissue was observed on the shaft.An infusion catheter was placed, a tpa drip was administered, and a plan was made to bring the patient back later in the day.As of (b)(6) 2022, there was flow to the foot, and the posterior tibial artery was open.Per the physician, the at and peroneal arteries were damaged by the event.

Manufacturer Narrative

H6: investigation findings code 4247: suggested code is foreign material on/in device.Device analysis conclusion: the oad was received at csi for analysis.As the guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the event.Visual examination of the oad revealed a white foreign material on and embedded within the driveshaft.The foreign material prevented a test wire from passing through.Scanning electron microscopy analysis found the white shredded substance containing mainly fluorine or ptfe with residues of solder and saline.It is unknown when the material became adhered or if it is related to the reported event.The identification and root cause of the foreign material accumulation is also unknown.It should be noted that the details reported to csi indicate treatment was intentionally planned for the distal two thirds of the sfa, where a preexisting stent was implanted.Per the diamondback 360 peripheral orbital atherectomy system instructions for use manual, use of the oas is contraindicated if the target lesion is within a bypass graft or stent.Review of the device data log did not reveal any issues that would have contributed to the reported event.The reports of slow flow and thrombus could not 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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL 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: 13403620
• MDR Text Key: 289258606
• Report Number: 3004742232-2022-00022
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)230831(10)392410-1
• 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,Followup
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 392410-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Race: White