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

Model Number	DBP-150CLASS145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received for analysis.Adhered material was observed on the proximal edge of the oad crown.There was no damage observed that would have contributed to the accumulated material.The morphology and exact root cause of the material accumulation is unknown.An attempt to pass a test guide wire through the oad was made, but the guide wire would not pass through the area with adhered material.Destructive analysis revealed adhered material embedded within the driveshaft filars.Functional testing of the oad revealed that the oad spun at all speeds and functioned as intended.At the conclusion of the device analysis, the reported event of the device being stuck on the guide wire was unable to be conclusively confirmed as the guide wire was not returned.The reported event of the guide wire would not pass through the device was confirmed.Although the root cause of the accumulating material was unknown, it was hypothesized that the device driveshaft became stuck on the guidewire after seizing due to the material accumulation.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.Csi id# (b)(4).
Event or Problem Description
During a procedure, the diamondback peripheral orbital atherectomy device (oad) was used to treat a 99% stenosed target lesion located in the posterior tibial artery (pt).The lesion was severely calcified and the artery was not tortuous.After four treatment passes, the oad became stuck on the guide wire.The oad and guide wire were removed from the patient together, and the guide wire was removed from the rear of the oad.The vessel was re-wired with a second guide wire, and rewiring resulted in a delay of approximately 20 minutes to the procedure.The second guide wire would not pass through the initial oad, and multiple attempts at balloon angioplasty were performed.The distal vessel was not able to be opened, and no additional treatment was reported in the posterior tibial artery.A second oad was used to continue the procedure in the superficial femoral artery (sfa) and popliteal artery.After treatment in the sfa and popliteal, balloon angioplasty was performed.After balloon angioplasty, a type b dissection was observed.The physician stated the second oad did not contribute to the dissection.

• 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: 8799425
• Report Number: 3004742232-2019-00186
• Device Sequence Number: 14223506
• Product Code: MCW
• UDI-Device Identifier: 10852528005251
• UDI-Public: (01)10852528005251(17)210430(10)265869
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/17/2019

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: 04/30/2021
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: DBP¿150CLASS145
• Device Lot Number: 265869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 91