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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was received at csi for analysis.Initial visual and tactile inspection of the handle assembly, saline sheath and driveshaft revealed the nose cone strain relief to be detached from the nose cone assembly.The nose cone clips, saline sheath and driveshaft in that area were damaged as a result of some form of impact.Further examination revealed evidence of blood residue within the sheath.Saline was injected into the handle and was noted to flow out of the nosecone, indicating no blockages in flow.There was no other damage observed with the oad that would have contributed to the reported event.The device was tested, and operated as intended.At the conclusion of the device analysis, the reported nose cone detachment was confirmed, though the root cause of the damage could not be determined.The device history record for this device lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event and the device met material, assembly, and quality control requirements prior to distribution.(b)(4).
Event or Problem Description
During a procedure, a piece of the nose cone of the peripheral diamondback orbital atherectomy device (oad) became detached.The nose cone was reattached and reloaded over the viperwire.Blood began to backfill into the oad during insertion of the oad into the introducer sheath.Saline was observed flowing from the nose cone area.The procedure was completed with a second oad and planned angioplasty and stent placement.There were no other complications, and the patient was discharged.
Additional Manufacturer Narrative
Additional information: the patient was in her mid-60's.The exact age of the patient is unknown.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: 8499031
• Report Number: 3004742232-2019-00102
• Device Sequence Number: 16635566
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)201231(10)251792
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/12/2019

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: 12/31/2020
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 251792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR