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 Perforation of Vessels (2135)

Event Date 05/28/2020

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.Csi id: (b)(4).

Event Description

A diamondback peripheral orbital atherectomy device (oad) was used to treat a lesion in the tibial artery.During treatment, the oad became stuck on the guide wire and stopped spinning.Glide assist mode was activated in an attempt to disengage the device from the guide wire, however it was unsuccessful, and the oad and guide wire were manually removed by pulling.Tissue was observed to be wrapped around the device, and a resultant vessel perforation was identified.The tibial artery was re-wired and balloon angioplasty was performed.Everything looked good post-angioplasty.

Manufacturer Narrative

The oad and guide wire were received at csi for analysis.Visual examination revealed dried biological fluid on the driveshaft and crown.This did not prevent the guide wire from passing through the driveshaft.The morphology and root cause of the accumulation was unknown.The guide wire spring tip proximal coil was stretched but remained intact.Visual analysis did not identify any damage that would have contributed to the reported events.The oad data log was reviewed.The data showed the device had stalled as well as slowed down during the procedure.However, the device functioned as intended during testing.The stalls and decreases in speed observed in the data log could not be duplicated during analysis.It is hypothesized that the oad crown was placed within a tight location of the lesion and did not have sufficient space to begin spinning before treatment, however this could not be confirmed.At the conclusion of the device analysis investigation, the reported perforation and device stuck on wire events could not be confirmed.Although the stalls observed in the data log could not be replicated during analysis, it is possible they may be related to the stuck on wire complaint 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.Updated fields: b4, g4, g7, h2, h3, h6, h10.Csi id: (b)(4).

• 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
• MDR Report Key: 10199842
• MDR Text Key: 196581599
• Report Number: 3004742232-2020-00176
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)211130(10)297331
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 297331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention