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

Model Number DBP-125MICRO145

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.(b)(4).

Event Description

Following four treatments with a diamondback peripheral orbital atherectomy device (oad) in the mid posterior tibial (pt) artery, which was 95% stenotic, the oad could not be advanced to the distal pt.The vessel diameter was 3mm.The oad was set to low speed, but another attempt to advance to the distal pt was unsuccessful.The oad and wire were removed.The viperwire was replaced as a troubleshooting measure, however advancement of the oad over the wire seemed difficult.The device was then advanced to the distal pt and six more treatments were administered.The oad was advanced distally but became stuck on the viperwire.The oad and wire were removed from the patient.The procedure was completed with balloon angioplasty, and the outcome was good.There were no patient complications.The procedure was delayed by at least 30 minutes.

Manufacturer Narrative

Failure analysis conclusion at the conclusion of the failure analysis investigation the reported event was not confirmed.An in-house 0.014" test wire was able to pass through this area of tissue with minimal resistance.There was some adhered biological material on the distal and proximal edges of the crown and driveshaft.The exact root cause of accumulating tissue remains unknown.The outside diameter (od) of the crown was measured using a calibrated dial caliper and was found to meet specification.There was no damage observed with the oad that would have contributed to the positioning/advancement difficulty or the stuck-on-guidewire event.As the original guidewire was not returned it could not be determined if it was damaged or whether it contributed to the reported event.Although the root cause of the reported complaints are undeterminable, it is possible that the accumulated biological material could have contributed to events experienced during the case.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.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 hwy 8 nw; st. paul MN 55112
• MDR Report Key: 8282362
• MDR Text Key: 134368868
• Report Number: 3004742232-2019-00038
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005282
• UDI-Public: (01)10852528005282(17)200331(10)219478
• Combination Product (y/n): N
• PMA/PMN Number: K133399
• 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: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: DBP-125MICRO145
• Device Lot Number: 219478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 81