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

Model Number VPR-GW-14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/24/2019

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 procedure, the viperwire guide wire spring tip fractured when the orbital atherectomy device (oad) made contact with the distal end coil of the guide wire.The first target lesion was located next to a previously implanted stent, in the left mid-distal superficial femoral artery(sfa) and the second lesion was located distal to that previously implanted stent.The guide wire was looped prior to treatment in an attempt to prevent the tip of the guide wire from making contact with the vessel.The oad was successfully operated in the left mid-distal sfa and then was advanced to the second lesion distal to the stent.During treatment the viperwire was observed to have engaged with the oad, and it appeared to have fractured.An angiogram revealed no damage to the vessel, and treatment was continued as intended with balloon angioplasty and stent placement.Once treatment was completed, the guide wire fragment was retrieved with the use of a snare.There were no adverse events reported for the patient.

Manufacturer Narrative

The viperwire guide wire and spring tip fragment were returned to csi for analysis.Examination of the returned guide wire revealed the spring tip support ribbon and core shaft to be fractured distal to the proximal solder bond.Scanning electron microscopy analysis revealed rotational damage and fatigue striations, which were consistent with a fractured spring tip resulting from oad contact with the spring tip.At the conclusion of the device analysis, the reported event that the guide wire fractured was confirmed.The root cause was due to the oad coming into contact with the guide wire spring tip.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 the instructions for use of the peripheral diamondback orbital atherectomy system states: "a minimum distance of 10 cm must be observed throughout treatment between the guide wire spring tip and distal tip of the oad shaft to prevent damage to the guide wire spring.Advance the guide wire further distal, if necessary to maintain minimum 10 cm distance.Never bring the oad shaft tip into contact with the guide wire spring tip." (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 55112
• MDR Report Key: 9220416
• MDR Text Key: 163204602
• Report Number: 3004742232-2019-00272
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491158
• UDI-Public: (01)10850000491158(17)210131(10)258536
• 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: 12/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: VPR-GW-14
• Device Lot Number: 258536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 115