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

Model Number	DBP-150SOLID145
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(6).
Event or Problem Description
Fluid leaked from the handle and saline tubing of the diamondback peripheral orbital atherectomy device (oad) during device preparation.The saline did not flow out of the tip of the oad.A second oad was used to complete the procedure, and there were no patient complications.The patient was well following the procedure.
Additional Manufacturer Narrative
At the conclusion of the failure analysis investigation the reported leaking event was confirmed.Detailed analysis of the handle assembly revealed the saline sheath to be separated from the glue plug.The proximal saline sheath separation site did not show signs of tensile or impact damage.Further analysis of the nose cone assembly revealed a manufacturing issue; the saline sheath material was not positioned properly.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.Cs 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: 8523335
• Report Number: 3004742232-2019-00107
• Device Sequence Number: 2689471
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)201231(10)250625
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/09/2019

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: 250625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 05/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1