MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number DBP-125MICRO60

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Vessels (2135)

Event Date 03/15/2017

Event Type  Injury  

Manufacturer Narrative

Device evaluation is in process.A supplemental report will be submitted for failure analysis.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a perforation occurred while using a csi orbital atherectomy device (oad).The target lesion was 5 mm in length and was located in the anterior tibial (at) artery.During the third run at low speed, the device pitch changed.The oad was removed and angiography revealed a perforation.The physician inflated a balloon across the perforation for three minutes and successfully resolved it.The patient status remained stable throughout the procedure.Additional information was requested, but was denied by the facility.

Manufacturer Narrative

Device analysis: the oad was returned without the original guide wire.The initial visual and tactile examination of the handle assembly, saline sheath, and driveshaft did not reveal any damage.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and edges of the crown.Examination in the areas of the adhered material did not reveal any damage that would have contributed to the accumulation.There was no damage observed with the oad that would have contributed to the reported event.An in-house 0.012" test wire was loaded through the device and passed through the area of adhered tissue without issue.When tested, the device spun at low, medium, and at high with no abnormalities observed.The device was turned on and off numerous times with no issues observed.While performing functional testing the power cord, brake, and control knob were manually manipulated to determine if there were any functional concerns with the components that would have contributed to the reported event.The device and components functioned as intended with no abnormalities observed.There was no other damage observed with handle assembly that would have contributed to the difficulties experienced during the procedure.The outside diameter (od) of the crown and spring tip solder bonds were measured using a calibrated dial caliper met the drawing specifications.The placement of the crown also met the drawing specifications.At the conclusion of the failure analysis investigation, the root cause of the perforation could not be determined.(b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: jacob mellem ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 6491494
• MDR Text Key: 72779848
• Report Number: 3004742232-2017-00031
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005206
• UDI-Public: (01)10852528005206(17)181031(10)172668
• 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,Followup
• Report Date: 04/13/2017

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
• Device Operator: Physician
• Device Expiration Date: 10/31/2018
• Device Model Number: DBP-125MICRO60
• Device Catalogue Number: DBP-125MICRO60
• Device Lot Number: 172668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 03/15/2017
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2016
• 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