MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number DBP-125SOLID145

Device Problem Entrapment of Device (1212)

Patient Problem Vascular Dissection (3160)

Event Date 04/19/2018

Event Type  Injury  

Manufacturer Narrative

The reported oad was returned for analysis with the guide wire engaged in the device.The guide wire was removed from the oad with some resistance.Adhered biological material was found on the driveshaft and crown, however the material did not prevent the guide wire from passing through the driveshaft.The source of the biological material is unknown.There was no additional damage observed with the device or guide wire which would have contributed to the reported event.When tested, the oad functioned as intended with no anomalies noted.At the conclusion of the device analysis investigation, the reported event was unable to be confirmed.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).

Event Description

During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a dissection occurred.Lesions in three segments of the anterior tibial artery were treated using multiple passes with the oad on low, medium and high speeds.When the oad was activated again following a rest period, the device stalled and became stuck on the guide wire.The oad and wire were removed together and when imaging was performed a dissection was noted.Bypass surgery was performed to resolve the dissection.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; saint paul, MN 55112
• MDR Report Key: 7522852
• MDR Text Key: 108545652
• Report Number: 3004742232-2018-00133
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005244
• UDI-Public: (01)10852528005244(17)181231(10)178639
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2018

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: 12/31/2018
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 178639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2016
• 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