MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number DBP-125MICRO145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160)

Event Date 10/09/2023

Event Type  Injury  

Event Description

A diamondback 360 peripheral orbital atherectomy device (oad) was used for an atherectomy procedure.A perforation was observed.

Manufacturer Narrative

The investigation is ongoing.A final report will be submitted once the investigation is complete.Csi id: (b)(4).

Manufacturer Narrative

Updated fields: b4, d4, d9, g3, g6, h2, h3, h4, h6, h6 investigation conclusion code 22: the diamondback 360® peripheral orbital atherectomy system instructions for use manual states that vessel perforation is a potential adverse event that may occur and/or require intervention with use of the system.H6: investigation findings code: 4247 - suggested code is biological material present on device.The oad was returned for analysis.Examination of the driveshaft crown section identified adhered biological material.It was unable to be determined whether the adhered biological material was related to the perforation.The morphology and exact root cause of the biological material was unknown.Examiniation of the crown did not reveal any damage or abnormalities that could have led to the perforation.The crown diameter was measured and met specification.The root cause of the perforation was unable to 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)(6).

Manufacturer Narrative

Updated fields: b4, b5, g2, g3, g6, h2, h6.

Event Description

Additional information received indicated during the procedure, the oad arrested on the viperwire advance guide wire and was unable to be removed.An advanced technique was used to remove the oad and guide wire.A proximal anterior tibial dissection was observed.Balloon angioplasty was used to treat the dissection, and subsequently complete the procedure.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• 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: aaron stevens ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18058259
• MDR Text Key: 327201703
• Report Number: 3004742232-2023-00270
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)241031(10)458781-1
• 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: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 458781-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Male