MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. VIPERWIRE; CORONARY ATHERECTOMY DEVICE

Model Number	GWC-12325LG-FLP
Medical Device Problem Codes	Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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).
Event or Problem Description
The treatment area was a heavily calcified circumflex artery.After placement of a non-abbott catheter, the coronary orbital atherectomy device (oad) and viperwire coronary advance guide wire were advanced distally.During therapy, the tip of the driveshaft was advanced within the 5mm minimum and this was difficult to visualize due to the patient's body habitus.Imaging results showed that the oad appeared to be close to the guidewire.The imaging was poor due to the size of the patient.The physician was advised to advance the viperwire guide wire away from the oad tip.Four low speed treatments were performed.Fluoroscopy imaging was checked but due to the anatomy of the patient, the imaging was not clear, however, a guidewire fracture was observed.The fractured component was in the side branch of the marginal artery and about 2.5 cm in length which was left in-vivo.The physician did not have any concerns for the long-term effects to the patient.A teleport guide catheter was advanced, and a wire exchange was performed for a non-abbott wire.Angioplasty and stent placement were performed to complete the procedure.The patient was stable.

• Brand Name: VIPERWIRE
• Common Device Name: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INC.; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer Contact: keerthi bangalore ramanath ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 20333841
• Report Number: 3004742232-2024-00346
• Device Sequence Number: 15454739
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)241130(10)6741717
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 6741717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 163 KG
• Patient Race: White