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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/03/2021
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.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.An attempt was made to obtain additional information and opinion from the physician regarding csi's role in the events reported.No response was received.Csi id: (b)(4).
Event or Problem Description
The diamondback peripheral orbital atherectomy device (oad) was used for treatment via left femoral access in the right anterior tibial (at) artery.The vessel size appeared to be greater than 2mm.Treatment was performed in the proximal and mid at.Distal treatment was performed on low and medium speed.High speed was selected for treatment in the distal lesion, and the oad stalled and became stuck in the vessel.In the process of the user attempting to manipulate the oad, the wire came back and became stuck in the driveshaft.Nitroglycerin was administered.A second wire could not be advanced due to anatomical considerations.The physician cut the driveshaft and advanced a larger sized catheter over the driveshaft in an unsuccessful attempt to remove the device.The patient was sent to the operating room for further intervention.Thereafter, a possible dissection and intimal damage was observed.Medical staff stated the procedure had been a last attempt prior to amputation.The right lower limb was reportedly amputated.The patient was stable condition after the procedure.

• Brand Name: DIAMONDBACK 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: 11229372
• Report Number: 3004742232-2021-00017
• Device Sequence Number: 3502156
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)201031(10)245237
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 01/26/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 245237
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2021
• Initial Report FDA Received Date: 01/26/2021
• 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; Disability
• Patient Age: 67 YR
• Patient Weight: 100