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

Model Number DBP-200SOLID145

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2022

Event Type  Injury  

Event Description

A diamondback peripheral orbital atherectomy device (oad) was used via left common femoral (cfa) access and contralateral approach.A 6fr sheath was used.Atherectomy was planned for a right cfa lesion.A viperwire was used to wire the vessel, and a non-csi filter was deployed in the proximal to mid superficial femoral artery (sfa).The oad was then advanced, and atherectomy was performed without issue.During removal the oad crown became entrapped in the right external iliac artery.(this lesion had not appeared angiographically significant.) the sheath was above/proximal to where the crown had become entrapped.Multiple unsuccessful attempts were made to remove the oad.The oad could be activated, but it would stall each time.A non-csi wire was advanced to aid in removal of the oad.In the opinion of the physician , the patient's anatomy was the cause of the oad becoming entrapped.The filter became entrapped at the same location later in the procedure.

Manufacturer Narrative

Device analysis conclusion: the oad was returned to csi for analysis.There was no damage observed with the driveshaft or handle assembly that would have contributed to the reported event.The oad functioned as intended during testing.Review of the device data log identified stall events during the procedure.This could not be replicated during failure analysis.It is unknown if the stall events are related to the report that the device became stuck in the vessel.As the guidewire was not returned for analysis, it could not be determined if it was damaged or contributed to the reported complaint.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: 14102586
• MDR Text Key: 289182211
• Report Number: 3004742232-2022-00090
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)230228(10)369928-1
• 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
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 369928-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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 Sex: Female