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

Model Number	DBP-200SOLID145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported oad was returned for analysis with the guide wire engaged in the device.Analysis of the handle revealed the saline sheath, driveshaft, and engaged guide wire to have been destructively cut.All cut sections exhibited adhered dried biological material.The cut and deformed driveshaft and guide wire sections are the result of the surgical intervention performed to remove the device from the patient.Further examination revealed the oad crown and guide wire spring tip to be intact and undamaged.When tested, the device functioned as intended with no abnormalities observed.There was no damage observed with the oad or guide wire sections that would have contributed to the reported event.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.(b)(4).
Event or Problem Description
During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a dissection was noted.The target lesion was 60% stenosed and located in the distal superficial femoral artery (sfa).The lesion was treated using one pass with the oad at low speed and one pass at medium speed.Following the second pass with the oad, a dissection was noted and the oad became stuck in the patient.Surgery was performed to resolve the dissection and remove the oad, and the patient was stable following the procedure.

• 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: 7383456
• Report Number: 3004742232-2018-00084
• Device Sequence Number: 13757048
• Product Code: MCW
• UDI-Device Identifier: 10852528005275
• UDI-Public: (01)10852528005275(17)190930(10)203457
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 03/29/2018

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: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: DBP¿200SOLID145
• Device Lot Number: 203457
• 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
• Initial Report FDA Received Date: 03/29/2018
• 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: 60 YR
• Patient Weight: 66