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

Model Number	DBE-200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The oad was received for analysis.Visual examination revealed an insufficient amount of uv adhesive in the seal around the nosecone cap.A syringe filled with fluid was injected into the oad and the fluid was observed to be leaking out of the nosecone cap.There was no other damage observed with the oad.At the conclusion of the analysis, the reported issue that the oad was found to be leaking was confirmed.The root cause was revealed to be a manufacturing issue where an insufficient amount of adhesive had been applied at the nosecone cap.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).
Event or Problem Description
During priming of the peripheral stealth orbital atherectomy device (oad), the oad was noted to be leaking viperslide from the strain relief.The oad was advanced through the sheath and blood was noted to be flowing back through the saline sheath.The device was replaced with a second oad to complete the procedure and there were no patient complications.

• 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: 8583728
• Report Number: 3004742232-2019-00128
• Device Sequence Number: 2016664
• Product Code: MCW
• UDI-Device Identifier: 10852528005022
• UDI-Public: (01)10852528005022(17)211231(10)251125
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• 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): 05/06/2019

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: 12/31/2018
• Device Model Number: DBE-200
• Device Catalogue Number: 70056-02
• Device Lot Number: 251125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1