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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Vessel Or Plaque, Device Embedded In (1204); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.(b)(4).
Event or Problem Description
Treatment of a lesion in the superior femoral artery (sfa) with a 2.0mm diamondback peripheral orbital atherectomy device (oad) via contralateral femoral approach was successful.The viperwire was exchanged for a workhorse wire, which was used to gain access in the at.The workhorse wire was then exchanged for the viperwire.A 1.25mm oad was used for further treatment, but became stuck after about 4cm of the lesion was treated.The saline sheath of the oad was used in attempt to free the crown, but the attempt was not successful.Multiple other troubleshooting attempts were unsuccessful in freeing the oad, and the procedure was delayed by more than an hour.The device was removed surgically, and unobstructed flow to the affected area was noted.Additional information was requested but not received.
Event or Problem Description
Treatment of a lesion in the superior femoral artery with a 2.0mm diamondback peripheral orbital atherectomy device (oad) via contralateral femoral approach was successful.The viperwire was exchanged for a workhorse wire, which was used to gain access in the anterior tibial artery.The workhorse wire was then exchanged for the viperwire.A 1.25mm oad was used for further treatment, but became stuck in a moderately calcified 20mm long lesion after about 4cm of the lesion was treated.Multiple troubleshooting attempts were unsuccessful in freeing the oad, and the procedure was delayed by more than an hour.The device was removed surgically, but a fragment of the device could not be removed.The patient was well following the procedure.The fragment remains in vivo and is embedded in tissue but is not obstructive.
Additional Manufacturer Narrative
Additional information: 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).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8607326
• Report Number: 3004742232-2019-00135
• Device Sequence Number: 19406820
• Product Code: MCX
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)201231(10)252456
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 252456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR