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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis.A guide wire was advanced through the device and met resistance proximal to the driveshaft tip bushing.Examination of the area revealed embedded biological material within the driveshaft filars.When this area was destructively removed, the guide wire was able to pass through the device with no resistance.The oad was tested and was found to spin at all three speeds with no abnormalities observed.As the original guide wire utilized during the procedure was not returned for analysis, it could not be determined if it contributed to the reported event.At the conclusion of the device analysis investigation, the reported inability of the device to advance over the guide wire was confirmed to be due to embedded biological material in the driveshaft.However, the source of the biological material was unable to be determined.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.(b)(6).
Event or Problem Description
During a procedure the diamondback peripheral orbital atherectomy device (oad) would not advance past the mid-superficial femoral artery (sfa).A kink was observed on the viperwire, although the kink was not within the oad and was ex vivo at the time that the advancement difficulty was encountered.The viperwire was exchanged for a second viperwire, but again the oad would not advance past the sfa.The oad was removed.Over-the-wire balloons were used to continue the procedure but also would not advance past the sfa.The procedure was completed using a different guidewire and balloon angioplasty.The procedure was delayed by greater than 30 minutes, and the delay was attributed to the oad.

• 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: 8535773
• Report Number: 3004742232-2019-00110
• Device Sequence Number: 1730800
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)210131(10)256155
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Report Date (Section B): 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 256155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1