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

Model Number GWC-12325LG-FT

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/13/2020

Event Type  malfunction  

Manufacturer Narrative

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.Csi id: (b)(4).

Event Description

Strong resistance was encountered during wire exchange from a non-csi wire to viperwire.The viperwire became stuck on the microcatheter.The wire and microcatheter were removed together.The viperwire spring tip fractured, and the fragment was removed when the microcatheter and wire were pulled back; no additional intervention was needed.The procedure was continued with a second viperwire and without further issue.The patient was in good condition following the procedure.

Manufacturer Narrative

Updated data: b4, d9, g3, g6, h2, h3, h6, h10.Device evaulation conclusion: the guide wire was received at csi for analysis.Analysis did not reveal any damage with the guidewire or spring tip, no fractures were observed.At the conclusion of the device analysis investigation, the reported fracture could not be confirmed through analysis.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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: CORONARY ATHERECTOMY DEVICE (GUIDE WIRE)
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 10968856
• MDR Text Key: 228440009
• Report Number: 3004742232-2020-00395
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491141
• UDI-Public: (01)10850000491141(17)211130(10)304570
• Combination Product (y/n): N
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 01/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: GWC-12325LG-FT
• Device Lot Number: 304570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Date Manufacturer Received: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1