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 Problems Thromboembolism (2654); Foreign Body In Patient (2687)

Event Date 08/25/2017

Event Type  Injury  

Manufacturer Narrative

Device analysis: the original guide wire was discarded and not returned to csi.A second wire from the same lot number was returned by the facility.Analysis of the returned wire did not reveal any issues or abnormalities with the wire.The material inspection report for this guide wire 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.At the conclusion of the investigation, the root cause of the event could not be determined.(b)(4).

Event Description

It was reported that during a peripheral orbital atherectomy procedure, the tip of a csi viperwire guide wire broke off and was left in the patient.The target lesion was located in the superficial femoral artery (sfa).The physician had completed atherectomy and removed the device and guide wire from the patient.The tip of the wire was unknowingly left in the patient, but later, the patient experienced thrombus and clotting issues and was admitted to the icu.At that point, it was realized that the tip of the wire had been left in the patient.The tip of the wire was snared from the patient and the patient was treated with thrombolytic therapy.The original guide wire was discarded.Additional information was requested, but none has yet been received.

• 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
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: jacob mellem ; 1225 old highway 8 nw; saint paul, MN 55112 ; 6512592819
• MDR Report Key: 6975835
• MDR Text Key: 90174337
• Report Number: 3004742232-2017-00106
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005312
• UDI-Public: (01)10852528005312(17)190630(10)196571
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2019
• Device Model Number: VPR-GW-FT14
• Device Catalogue Number: VPR-GW-FT14
• Device Lot Number: 196571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2017
• 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 Outcome(s): Other