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

Model Number DBP-EX-125SOL145

Device Problem Material Separation (1562)

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

Event Date 01/17/2023

Event Type  malfunction  

Event Description

During treatment, the diamondback 360 exchangeable peripheral orbital atherectomy device (oad) became stuck on the viperwire advance guide wire.The oad and viperwire were removed and replaced.The patient was stable.During analysis of the oad, spring tip damage was observed.It was unknown when the damage occurred.

Manufacturer Narrative

The oad was returned to csi for analysis with the guide wire not engaged.Visual examination revealed spring tip damage with the coils unraveled and most of the distal section missing.Scanning electron microscopic analysis identified that the core wire was fractured within the spring tip at the round to flat transition section.The fracture shows evidence of tensile failure, however, the root cause of the damage was unable to be 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 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: tonia moskalets ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 16566908
• MDR Text Key: 311702326
• Report Number: 3004742232-2023-00069
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005824
• UDI-Public: (01)10852528005824(17)240731(10)443130
• 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: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-EX-125SOL145
• Device Catalogue Number: 7-10030-02
• Device Lot Number: 443130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2022
• 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