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

Model Number DBP-125MICRO145

Device Problem Entrapment of Device (1212)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 12/03/2018

Event Type  Injury  

Manufacturer Narrative

Analysis of the reported device is in progress. A supplemental report will be submitted when the device analysis is completed. (b)(4).

Event Description

During a peripheral atherectomy procedure using a csi diamondback orbital atherectomy device (oad), the device became stuck in the lesion. The target lesion was 80% stenosed and located in the anterior tibial artery (at). The lesion was wired and the oad inserted, however it would not cross the lesion. Balloon angioplasty was performed, following which the oad was reinserted and successfully crossed the lesion. The lesion was treated with one pass at low speed and one pass at medium speed. When an attempt was made to remove the device, resistance was experienced. The device was tugged but was unable to be removed from the patient, and the guide wire was noted to be kinked. The guide wire was removed and a non-csi guide wire was inserted into the oad, however it coiled inside the device and was unable to be inserted. The oad was destructively cut and an additional wire was inserted in order to remove the device. Balloon angioplasty was performed to complete the procedure and the patient was in stable condition.

• 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 ; 6512591600
• MDR Report Key: 8199467
• MDR Text Key: 131502500
• Report Number: 3004742232-2018-00383
• Device Sequence Number: 1
• Product Code: MCW
• 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

• Type of Report: Initial,Followup
• Report Date: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 243319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/27/2018 Patient Sequence Number: 1