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

Model Number	DBP-150CLASS145
Medical Device Problem Codes	Entrapment of Device (1212); Noise, Audible (3273)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id# (b)(4).
Event or Problem Description
During a procedure, the diamondback peripheral orbital atherectomy device (oad) was unable to be removed from the vessel.The target, 80% stenosed lesion was located in an area of the mid-anterior tibial artery that was 3.00mm in diameter.Following two treatment passes, the crown was stuck on something, and the device made an unusual noise.The crown would move forward in the vessel but would not back through the vessel.It was noted the crown was stuck in the vessel, and a perforation had occurred.The patient was transferred for surgical removal.The removal was successful, and the patient was fine following the removal.
Additional Manufacturer Narrative
The reported oad was received for analysis along with the guide wire used in the procedure.The oad driveshaft was observed to have been destructively cut near the strain relief and the lap weld.Adhered material was observed on the driveshaft crown section, and the driveshaft section also had adhered material and was damaged and deformed.A test guide wire was not able to pass through the areas with adhered material.The morphology and exact root cause of the material accumulation was unknown, however, it was hypothesized that the driveshaft crown became stuck in the vessel after seizing due to the material accumulation.It was also observed that the y-adaptor of the saline line was fractured.A test guide wire was passed through the oad and remaining driveshaft without issue.During testing, the oad spun at all speed with no unusual noises heard, and the oad functioned as intended.The spring tip of the returned guide wire was observed to be damaged and have a deformed proximal coil.The guide wire was intact, with no fractures observed.At the conclusion of device analysis, the reported event of the crown being stuck, the device made an unusual sound, and a perforation occurred was partially confirmed.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.Csi id# (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; saint paul MN 55112
• MDR Report Key: 8804097
• Report Number: 3004742232-2019-00185
• Device Sequence Number: 320780
• Product Code: MCW
• UDI-Device Identifier: 10852528005251
• UDI-Public: (01)10852528005251(17)210430(10)265395
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K133399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: DBP¿150CLASS145
• Device Lot Number: 265395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR