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

Model Number DBP-125MICRO145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 11/12/2017

Event Type  Injury  

Manufacturer Narrative

The distal driveshaft, saline sheath, and engaged guide wire section were returned for analysis without the oad handle.Examination of the saline sheath and driveshaft sections revealed them to have been destructively cut.The driveshaft filars were found to be stretched and there was adhered biological material on the driveshaft, crown, and exposed guide wire shaft at the tip bushing.Examination in the area of adhered material did not reveal any damage that would have contributed to the accumulation.There was no damage observed with the driveshaft and crown that would have contributed to the reported event.The guide wire exhibited numerous bends along the shaft.Examination of the remaining guide wire shaft did not reveal any additional damage that would have contributed to the reported event.At the conclusion of the device analysis investigation, the root cause of the reported event was unable to be confirmed.(b)(4).

Event Description

During a peripheral orbital atherectomy procedure using a csi orbital atherectomy device (oad), it was reported that a perforation occurred.The target lesion was heavily calcified, and was accessed through the groin.The lesion was treated using two passes with the oad, however the device then became stuck in the vessel.A cutdown was performed to remove the device, and the guide wire was noted to be kinked.Imaging was performed and a perforation was noted in the lateral plantar artery.The perforation was resolved without further intervention, and the patient was in stable condition following the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old hwy 8 nw; saint paul, MN 55112
• MDR Report Key: 7070544
• MDR Text Key: 93320802
• Report Number: 3004742232-2017-00145
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005251
• UDI-Public: (01)10852528005251(17)190531(10)191750
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2019
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 191750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention