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

Model Number	DBP-125SOLID145
Medical Device Problem Codes	Off-Label Use (1494); Difficult to Remove (1528); Material Separation (1562); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Reduced Blood Flow (4598)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During right peripheral angiogram procedure to treat a right toe ulcer, a 90cm 6f non-ci/abbott sheath was placed via a non-csi/abbott guidewire.A non-csi/abbott catheter was used to cross the lesions and an abbott command wire was switched out for the viperwire advance guidewire via the non-csi/abbott catheter.The non-csi/abbott catheter was removed, and a diamondback 360 peripheral orbital atherectomy device (oad) was inserted over the viperwire advance guidewire.The oad was spun on low speed for 30 seconds, medium speed for 30 seconds and high speed for 10 seconds before a snagging noise was heard and the oad shut off.The physician attempted to remove the oad leaving the wire, but the guidewire was stuck and was removed along with the oad.It was then noticed that the spring tip of the guidewire was broken and was lodged somewhere in the distal anterior tibial (at) artery.The oad and the guidewire were removed together from the patient's body.Upon inspection, it appeared that a stent was wrapped around the driveshaft of the oad.Earlier images of the oad did not show an obvious stent in the at, however the vessels were very calcified and there was some movement in the previous images.In one of the images, there was some appearance that looked like it could have been a stent but could not be 100% due to vessel disease and image quality.The at was rewired using an abbott command wire and ballooned using a 3.0mmx240mm jade balloon.Images post percutaneous transluminal angioplasty showed transient no flow in the vessel and two non-csi/abbott stents were placed in the at.Imaging following this procedure showed improved flow in the at and the final result was at artery being patent until the ankle.The procedure was delayed for more than 30 minutes due to complications.The tip of the viperwire was not retrieved since there was no equipment available long enough to reach it.Upon imaging, it appeared that the tip of the viperwire was lodged in some distal collateral and not in the main vessel lumen.
Additional Manufacturer Narrative
D10 continued: viperwire guidewire lot number- 501902-1, unique device identifier (udi)- (b)(4), manufacturing date- 10-jul-2023.Return of the device is anticipated.A supplemental report will be submitted when the investigation is complete.Csi id: (b)(4).
Additional Manufacturer Narrative
The guide wire and the oad were returned.The guidewire was returned fractured at the strain relief.Scanning electron micrroscope (sem) analysis of the fracture face shows evidence of ductile torsion.It is hypothesized that an extreme and abnormal stress condition existed in the area of the fracture that led to the failure.The root cause of the fracture remains undetermined.The guide wire was returned with a stent engaged.The removal of the stent from the patient is likely due to the oad crown spinning within the stent.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.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.Updated fields: b4, d9, g3, g6, h2, h3, h6 & h11.Csi complaints: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old hwy 8 nw; st paul, MN 55112
• MDR Report Key: 19667709
• Report Number: 3004742232-2024-00253
• Device Sequence Number: 12448926
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)250930(10)509742-1
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 509742-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 07/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VPR-GW-FLEX14.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Male