MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE); PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)

Catalog Number VPR-GW-14

Device Problems Entrapment of Device (1212); Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Date received by manufacturer: the event was reported to csi on (b)(6) 2020, but the report did not include reportable information at that time.Reportable information was provided on 10/4/2020.Device analysis conclusion: the oad was returned with the guidewire engaged.Analysis identified the wire as a wire intended for use with a peripheral oad.The oad was tested and functioned as intended.The failure is considered user error since an incompatible wire was used.At the conclusion of the device analysis investigation, the reported inability of the wire to advance through the oad was confirmed.The diamondback 360® coronary orbital atherectomy system instructions for use manual states, "do not use other commercially-available guide wires with the oad.Only use the model gwc-12325lg-flp viperwire advance® or gwc-12325lg-ft viperwire advance® with flex tip coronary guide wire with the coronary oad.The viperwire guide wire is designed for use with all coronary oad crown and shaft configurations." the material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.Csi id: (b)(4).

Event Description

The orbital atherectomy device (oad) could not be advanced over the viperwire during device preparation and loading.The wire became completely stuck in the oad and could not be removed.The procedure was continued with non-csi devices.The procedure was delayed by 30 minutes or more due to the issue.

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE)
• 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: 10733303
• MDR Text Key: 214800510
• Report Number: 3004742232-2020-00336
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190634
• 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
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VPR-GW-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1