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

Model Number VPR-GW-FT14

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Six treatments with the orbital atherectomy device were performed in the superficial femoral artery following failed delivery of the viperwire to the tibial artery after several attempts.During the attempts to deliver the wire to the tibial artery, the wire had folded several times.The tip of the wire broke off in situ near the aortic bifurcation during retraction, and a snare was used to remove the fragment.The patient was discharged as planned following the procedure.Approach for the procedure was contralateral, and the vessel was 80% stenotic with a type b lesion.

Manufacturer Narrative

The guide wire and spring tip were returned to csi for investigation with a fracture in the core located just proximal from the spring tip.Both the proximal and distal segments of the guide wire were returned.The wire core was deformed with a small radius bend at the fracture location, consistent with having been kinked prior to fracture.Scanning electron microscopy analysis revealed the presence of torsional stresses on the fracture faces of the core wires.However, the exact root cause of the fracture could not be determined.At the conclusion of the failure analysis investigation the event was confirmed.The ifu contains the following warnings: "handle the oad and guide wire carefully.A tight loop, kink, or bend in the guide wire may cause damage and system malfunction during use." and "a prolapsed or bent guide wire core can result in damage to the guide wire or oad." 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).

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 7998775
• MDR Text Key: 124799468
• Report Number: 3004742232-2018-00312
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)190630(10)198255
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 198255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 82