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

Model Number PRD-SC30-150

Device Problems Device Operates Differently Than Expected (2913); Failure to Shut Off (2939)

Patient Problem Vascular Dissection (3160)

Event Date 08/20/2015

Event Type  Injury  

Manufacturer Narrative

Csi is awaiting the return of the device for analysis.The facility is conducting their own internal analysis.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, a csi orbital atherectomy device (oad) would not shut off and the saline infusion pump had to be manually unplugged from the wall.Additionally, a dissection occurred in the superficial femoral artery (sfa).The target lesion was severely calcified, 90% stenotic and 15mm in length.It was located in the proximal sfa which had a reference vessel diameter of 5mm.The physician used a 6fr introducer sheath to access the lesion.A csi viperwire guidewire was advanced across the lesion and the oad was loaded onto it.The physician performed two successful runs at medium.During the third run at medium speed, the device bogged down, but atherectomy was continued.During the fourth run, the device made an unusual sound.When the physician attempted to turn off the oad, the power button was unresponsive.The saline infusion pump was unplugged from the wall.Post-atherectomy angiography revealed a dissection in the sfa.The physician resolved the dissection by deploying two stents.The patient status remained stable throughout the procedure.Three requests for additional information have been made, but none has yet been received.The device has also been requested for analysis, but is awaiting facility analysis and confirmation that csi will be able to obtain the device for analysis.

Manufacturer Narrative

Device is being retained by the facility and not returned to csi for analysis.(b)(4).Device retained by facility.

Event Description

No additional information will be received and the device is being retained by the facility.

• Brand Name: DIAMONDBACK 360 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: megan brandt ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 5085096
• MDR Text Key: 26111704
• Report Number: 3004742232-2015-00063
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005046
• UDI-Public: (01)10852528005046(17)180630(10)131296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 09/14/2015

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: 06/30/2018
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: PRD-SC30-150
• Device Lot Number: 131296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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