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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported oad was received at csi for analysis, with the guide wire engaged.Visual examination revealed the guide wire was seized within the driveshaft tip bushing area.Embedded biological material was observed within the tip bushing area.Examination of the area of adhered material did not reveal any damage that would have contributed to the material accumulation.The returned guidewire could not be removed from the driveshaft.When tested, the oad functioned as intended.At the conclusion of the device investigation analysis, the report that the device became stuck on the wire was confirmed.The morphology and exact root cause of the accumulation was unknown.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)(4).
Event or Problem Description
The diamondback peripheral orbital atherectomy device was operated in the popliteal artery at low speed for three treatment passes.The brake was unlocked and the oad was advanced to the next lesion.Three treatment passes were performed at low speed.As the oad was removed from the vessel, it was stuck on the guide wire and the guide wire moved with the oad.Despite troubleshooting attempts, the oad remained stuck on the guide wire.A second wire was inserted into the guide catheter to maintain wire access and the oad and wire were removed together.The procedure was continued with balloon angioplasty.A delay of 30 minutes or greater occurred due to this issue.

• 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: 10759125
• Report Number: 3004742232-2020-00325
• Device Sequence Number: 19632121
• Product Code: MCW
• UDI-Device Identifier: 10850000491196
• UDI-Public: (01)10850000491196(17)220630(10)332123
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/29/2020

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: 06/30/2022
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: 7-10057-03
• Device Lot Number: 332123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 67