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 Code	No Code Available (3191)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No code available - vessel spasm.Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id # (b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), vessel spasms occurred.The target lesions were located in the superficial femoral artery (sfa) and the ostial and distal anterior tibial (at) artery.It was reported that throughout the procedure vessel spasms occurred.Vasodilators were administered to resolve the spasms.Following treatment with the oad, the device became stuck on the guide wire.The oad and guide wire were removed and the lesion was rewired.Balloon angioplasty was performed and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
Corrected fields: d4, h4 h6: results code: 4247 - suggested code is biological material present on device.The reported oad was returned for analysis with the guide wire engaged in the device.Detailed analysis revealed adhered biological material on the driveshaft, crown, and on the guide wire located at the driveshaft tip bushing.Significant resistance was felt removing the guide wire from the handle assembly.There was no additional adhered biological material observed on the guide wire shaft.There was no other damage observed with the oad, guide wire, or spring tip that would have contributed to the reported event or the reported vessel spasms experienced during the procedure.During functional analysis, the returned guide wire was unable to be reloaded through the area of adhered biological material.The driveshaft was stretched distally to expose the embedded biological material within the driveshaft and crown section.This section of the driveshaft was removed and the guide wire was then able to pass through the handle assembly.The biological material adhering to the driveshaft and guide wire shaft could have contributed to the oad becoming stuck on the wire.Examination in the areas of the adhered tissue did not reveal any damage that would have contributed to the accumulation and the exact root cause of accumulating tissue remains unknown.When tested the device spun during all three speeds and functioned as intended with no abnormalities observed.At the conclusion of the device analysis investigation, the reported event of the device getting stuck on the guide wire was confirmed, however, we were unable to determine the root cause of the reported vessel spasms.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.A review of the guide wire lot number could not be performed as the lot number remains unknown.Csi id # (b)(4).Additional manufacturer narrative: a request was received 3 march 2020 to resubmit this report since the original submission (sent on 10 april 2018) included an inadvertently truncated mfr.Report number.See attached correspondence.The report is being re-submitted with as much of the original information as possible; however, the available h6 codes have since been updated.The original codes provided in the report were: method code(s): 38-34-84.Result code(s): 3049-463.Conclusion code(s): 77.It is currently unknown by csi staff what the original h6 codes entailed.Csi's current coding for these findings is represented in h6.

• 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: 7382838
• Report Number: 3004742232-2018-00085
• Device Sequence Number: 16452109
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)190930(10)203457
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 03/03/2020

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: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 210715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 03/29/2018
• Supplement Report FDA Received Date: 03/03/2020
• 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: 86 YR