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

Model Number	DBP-EX-125MIC145
Medical Device Problem Codes	Unintended System Motion (1430); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During a peripheral procedure to treat a calcified lesion in distal peroneal artery using a diamondback exchangeable peripheral orbital atherectomy device (oad) with antegrade femoral approach, the oad stalled on high speed after successful treatments on low and medium speeds and the distal wire access was lost.It was rewired and intervention was continued followed by percutaneous transluminal angioplasty.The oad and viperwire were removed together.Vessel spasm occurred in the patient.However, the procedure was successfully completed.Nitroglycerin and adenosine were administered to treat vessel spasm.The patient was in stable condition.In the physician's opinion, the oad caused and contributed to vessel spasm in the patient.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted once the investigation is complete.Csi id: (b)(4).
Additional Manufacturer Narrative
The peripheral exchangeable orbital atherectomy device (oad) and the flex tip guidewire were returned for analysis.During functional testing , a significant resistance when attempting to remove the guide wire was noted.The driveshaft and engaged wire were destructively cut proximal from the crown.The proximal guide wire section was removed from the handle assembly with resistance due to the shipping damage.The distal guide wire section was removed with significant resistance due to the adhered material.The test wire could not pass the adhered material but passed the remaining driveshaft and handle assembly without issue.Review of the device data log identified a stall event during the procedure.Examination did not reveal any damage that would have contributed to the material accumulation.The morphology and exact root cause of the accumulated biological material is unknown.When tested, the oad functioned as intended.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.Updated fields: b4, g3, g6, h2, h3, h6 (annex b, annex c, annex d) & h11.Csi id: (b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL
• 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: 19949396
• Report Number: 3004742232-2024-00300
• Device Sequence Number: 8856589
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)260131(10)523733
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/04/2024

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: 01/31/2026
• Device Model Number: DBP-EX-125MIC145
• Device Catalogue Number: 7-10030-01
• Device Lot Number: 523733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 183 KG
• Patient Race: White