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

Model Number VPR-GW-FLEX18

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  Injury  

Event Description

A viperwire guide wire was advanced past the popliteal artery, and a non-csi filter was deployed over the wire.Atherectomy was performed in the left distal superficial femoral artery (sfa) with a diamondback peripheral orbital atherectomy device (oad) which was then removed.The lesion was approximately 100mm in length, heavily calcified, and exhibited at least 4 mm of calcium.An angioplasty balloon was placed and inflated to nominal pressure and removed.A drug coated balloon (dcb) was then inserted over the wire, inflated for three minutes, and removed.A stent was then deployed in the popliteal vessel.Simultaneously, while the stent was being deployed, the filter pulled back, though both appeared intact.A non-csi balloon, that was not inflated, was then used to attempt to reposition the filter distal to the stent.The tip of the viperwire was then observed to have fractured.An attempt was made to retrieve the viperwire tip with the filter.The filter basket was retrieved, but the fragment remained in vivo.A snare was then used to capture the fragment from the tibioperoneal (tp) trunk.

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 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.Csi id: (b)(4).

• Brand Name: DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE)
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13978195
• MDR Text Key: 288394686
• Report Number: 3004742232-2022-00084
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005725
• UDI-Public: (01)10852528005725(17)231130(10)411221-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: VPR-GW-FLEX18
• Device Catalogue Number: 7-10041-04
• Device Lot Number: 411221-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• 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): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White