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

Model Number 7-10002

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation of Vessels (2135)

Event Date 12/03/2014

Event Type  Injury  

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a csi orbital atherectomy device (oad) bogged down and a vessel perforation occurred.The target lesion was located in the anterior tibial (at) artery which had a reference vessel diameter of 3.5mm.The physician used a treasure 12 guidewire from a pedal approach to access the lesion.The physician exchanged the treasure 12 wire for a csi viperwire guidewire and loaded the oad onto it.The lesion was treated with five runs at low speed using the csi oad, but during the final run, the device bogged down in the patient.Post-atherectomy ultrasound revealed a perforation at the site of treatment which was resolved using three balloon inflations (3 mins, 5 mins, and 10 mins.) the patient status remained stable throughout the intervention.Three requests for additional information have been made, but none has yet been received.

Manufacturer Narrative

Device analysis.The oad was received without the original saline line, guidewire or saline pump.The initial visual and tactile examination of the handle assembly, saline sheath and driveshaft did not reveal any damage that would have contributed to the reported event.Further examination revealed that the crown and distal tip bushing remained intact and undamaged.No biological material was observed on the driveshaft or crown.The crown, driveshaft, and nose length dimensions were measured and met their respective drawing specifications.An in-house 0.012" test wire was loaded through the handle assembly and passed with no resistance.When tested, the oad spun at low, medium and at high speed with no abnormalities observed.At the conclusion of the failure analysis investigation, the root cause of the device bogging down could not be determined.The root cause of the perforation also could not be determined.As the original guidewire was not returned for analysis, it could not be determined whether or not it was damaged or if it contributed to the difficulties experienced during the procedure.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).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 651 campus drive; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 651 campus drive; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 4376130
• MDR Text Key: 16083546
• Report Number: 3004742232-2014-00065
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133999
• 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: 12/29/2014

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
• Device Operator: Physician
• Device Expiration Date: 08/31/2016
• Device Model Number: 7-10002
• Device Catalogue Number: 7-10002
• Device Lot Number: 107268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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