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

Model Number DBP-125MICRO145

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Vessels (2135)

Event Date 11/03/2016

Event Type  Injury  

Manufacturer Narrative

Device analysis: the oad was returned with the original guide wire.The initial visual and tactile examination revealed that the driveshaft filars were stretched at the proximal edge of the crown, extending proximally.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.Biological material was observed on the driveshaft and crown, and embedded within the driveshaft tip bushing area.Examination of the driveshaft and crown in this area did not reveal any damage that would have contributed to the biological material accumulation.The initial visual and tactile examination of the exposed sections of the guide wire did not reveal any damage.Further examination revealed that the spring tip remained intact and undamaged.Biological material was observed on the shaft 18.5 cm from the distal end of the spring tip and under the driveshaft tip bushing location.Examination in the areas of the biological material did not reveal any damage that would have contributed to the accumulation.The guide wire was removed distally from the handle assembly with significant resistance.Examination of the remaining section of the guide wire did not reveal any damage.The returned wire was then attempted to be loaded through the handle assembly, but could not pass through.The driveshaft was destructively removed and the guide wire was then able to pass through without resistance.When tested, the device spun at low, medium and at high speed with no abnormalities observed.The outside diameter of the crown was measured using a calibrated dial caliper and met the drawing specifications.At the conclusion of the failure analysis investigation, the root cause of the device getting stuck on the guide wire was an accumulation of biological material on the driveshaft and guide wire.The root cause of the perforation could not be determined.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.The material inspection report for the viperwire guide wire was not reviewed as the lot number is unknown.(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 3mm in length, 99% stenotic, and was located in the anterior tibial (at) artery.The physician used a navicross introducer sheath and crossing guide wire to access the lesion.The physician exchanged for a csi viperwire guide wire and loaded the oad onto it.The physician completed one run at low speed for 30 seconds, one run at medium speed for 30 seconds, but during the final run at high speed, the device got stuck on the guide wire.The physician attempted to pull the oad out, but was unsuccessful.The device and guide wire were removed as a unit from the patient.The physician then attempted to re-wire the lesion, but was unsuccessful and angiography revealed a perforation.The patient was sent for surgical repair of the perforation and left the surgery in stable condition.

• 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 hwy 8 nw; saint paul, MN 55112 ; 6512592819
• MDR Report Key: 6136384
• MDR Text Key: 61158556
• Report Number: 3004742232-2016-00139
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)180630(10)165325
• 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: 11/18/2016

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: 06/30/2018
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 165325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention