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

Model Number DBP-125MICRO145

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Vessels (2135)

Event Date 02/24/2017

Event Type  Injury  

Manufacturer Narrative

Device analysis: the oad was returned with the original guide wire engaged in the device.The initial visual and tactile examination of the handle assembly, saline sheath, and driveshaft did not reveal any damage or abnormalities.Further examination revealed that the crown and distal tip bushing remained intact; however, the tip bushing exhibited minor surface wear.Biological material was observed on the driveshaft and crown.Further examination revealed that the proximal guide wire spring tip solder bond was engaged in the driveshaft tip bushing.Examination in the area of the adhered material did not reveal any damage that would have contributed to the accumulation.The outside diameter (od) of the crown was measured using a calibrated dial caliper and met the drawing specification.The placement of the crown and driveshaft dimensions also met the drawing specifications.The initial visual and tactile examination of the guide wire revealed that the spring tip exhibited deformed coils; however, the coils remained intact.The distal spring tip solder bond exhibited degraded solder material.Significant resistance was met while removing the guide wire distally from the driveshaft and tip bushing.The proximal solder bond was damaged and the spring tip coils were stretched and deformed during removal from the tip bushing.Examination of the remaining section of the guide wire revealed biological material on the shaft 10 cm proximal to the distal end of the spring tip.The spring tip and driveshaft tip bushing were sent for scanning electron microscope (sem) analysis.Sem analysis identified damage on the inner diameter of the driveshaft tip bushing and on the guide wire spring tip.The exact cause of the damage could not be determined.An in-house 0.014" test wire was loaded through the device, but met resistance when passing through the area of adhered biological material.When tested, the oad spun at low, medium, and at high speed 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.At the conclusion of the failure analysis investigation, the root cause of the perforation could not be determined.The root cause of the device becoming stuck on the guide wire could not be conclusively determined.The device history record for this oad lot number and the material inspection report for the guide wire lot number have 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 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 2 cm in length and was located in the anterior tibial (at) artery.The physician used a 6fr introducer sheath, 0.014" quickcross guide catheter, truepath guide wire and a csi viperwire guide wire to access the lesion.The oad was loaded onto the guide wire and advanced into the patient.While advancing the oad through the at artery the physician encountered areas of resistance, but was able to spin through them with short runs.The oad was advanced just proximal to the target lesion and the physician treated the lesion at low speed for 25 seconds.The physician was able to cross through the proximal segment of the lesion, but was unable to cross through the distal segment during the first run.A second run was performed at low speed, but the physician was still unable to cross the distal segment.At this point, the patient started to complain of leg pain.The physician attempted to remove the oad from the patient, but was unable do so as it was stuck on the guide wire.The physician removed the oad and guide wire as a unit from the patient.Post-atherectomy angiography revealed a perforation, which was resolved via balloon angioplasty.The patient status was stable at the end of the procedure.Additional information has been requested, but none has yet been received.

Manufacturer Narrative

(b)(4).

Event Description

It was identified via procedural notes that the physician was unable to improve inline flow to the foot at the completion of the procedure.

• 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: 6432513
• MDR Text Key: 70810904
• Report Number: 3004742232-2017-00018
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)180930(10)171310
• 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: 04/17/2017

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: 09/30/2018
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 171310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2016
• 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
• Patient Age: 65 YR