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

Model Number DBP-125MICRO145

Device Problems Entrapment of Device (1212); Unintended System Motion (1430)

Patient Problem Vascular Dissection (3160)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

The reported oad was received for analysis. Adhered biological material was observed on the crown, and embedded material was located in the driveshaft filars near the crown. Examination of the area did not reveal any damage that would have contributed to the accumulation. The morphology and exact root cause of the accumulating material was unknown. A guide wire was unable to pass through the area of embedded material. The guide wire was able to pass through the rest of the driveshaft and handle assembly with no resistance. The oad was tested, spun at all speeds, and functioned as intended with no issues observed. At the conclusion of the device analysis, the reported event was unable to be conclusively confirmed. The adhered material may have contributed to the reported event, however, this 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 procedure, the diamondback peripheral orbital atherectomy device (oad) was used to treat a 95% stenosed lesion in the proximal anterior tibial artery via posterior tibial access. The lesion was moderately to heavily calcified, and the vessel was 3. 5mm in diameter. The oad was used on low speed in a proximal to distal direction, and when medium speed was selected, the oad crown jumped. The oad was stuck on the wire, and low speed was selected to loosen it from the wire. The oad was then removed from the patient with a lot of resistance. A small, type a dissection was observed at the bend in the anterior tibial artery, and balloon angioplasty was used to resolve the dissection. The physician was concerned the oad may have fractured, and a second oad was used to continue the procedure in the posterior tibial artery. No physical damage was observed on the driveshaft or guide wire. The result of the procedure was good, and no additional patient complications were reported.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul, mn
• Manufacturer Contact: sarah hicks ; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 9917936
• MDR Text Key: 192394934
• Report Number: 3004742232-2020-00105
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 239043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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: 04/02/2020 Patient Sequence Number: 1