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

Model Number VPR-GW-EL14

Device Problems Entrapment of Device (1212); Material Deformation (2976)

Patient Problems Vascular Dissection (3160); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

Orbital atherectomy treatment was successfully performed via left radial access to the left popliteal (pa) and common femoral arteries without issue, and the orbital atherectomy device was removed from the patient's body.A balloon was inserted over the viperwire guide wire to treat the pa and balloon angioplasty was successfully performed.During the removal process the balloon became stuck, and the guide wire was pulled, however a kink was observed in the guide wire which prevented the balloon from being removed.The sheath, balloon and wire were pulled back into the mid aorta and access to the right groin was obtained in order to snare the wire from below, however this attempt was unsuccessful.The balloon, wire and sheath were then removed from the radial access site.Imaging was performed and confirmed a type f dissection in the axillary artery and a vessel spasm in the radial artery.Vascular surgery was consulted, and it was determined that no further treatment was required and the patient would be monitored, however the following day a coronary bypass surgery was performed.The patient was discharged in stable condition.

Manufacturer Narrative

The guide wire was received at csi for analysis, engaged in a balloon catheter.A visual examination of the wire confirmed multiple bends and kinks along the guide wire, with the spring tip remaining intact and undamaged.At the conclusion of the device analysis investigation, the report that the guide wire was kinked was confirmed, however the dissection and vessel spasm events could not be confirmed through analysis.The root cause of the damaged guide wire was hypothesized to be due to handling of the wire during the procedure.The diamondback peripheral orbital atherectomy system instructions for use manual states ""handle the oad and guide wire carefully.A tight loop, kink, or bend in the guide wire may cause damage and system malfunction during use." the material inspection report for this guide wire 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).

• 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
• MDR Report Key: 11890521
• MDR Text Key: 262657517
• Report Number: 3004742232-2021-00189
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005459
• UDI-Public: (01)10852528005459(17)230131(10)362913-1
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: VPR-GW-EL14
• Device Catalogue Number: 7-10035-01
• Device Lot Number: 362913-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 86