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

Model Number DBP-150CLASS145

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

Return of the device is anticipated.A supplemental report will be submitted when the investigation is complete.Csi id: 13865.

Event Description

A diamondback 360 peripheral orbital atherectomy device (oad) was used for treatment of a 99% stenosed, severely calcified lesion throughout the anterior tibial artery (at) via left peroneal pedal access.The at was 3mm in diameter.The non-csi guide wire was advanced up the peroneal and over into the at and was exchanged for viperwire at the foot.The viperwire tip was parked in dorsalis pedis (dp).The oad was advanced from at to dp and at treatment started but the scrub technician inadvertently pulled back the viperwire and spun over the viperwire tip resulting in the oad getting stuck.The viperwire was removed and rewiring from back end was unsuccessfully attempted.During oad removal attempts the crown became stuck in the distal part of the vessel.Attempts to get into the at via femoral access to balloon around it to dislodge the crown from the intima also failed.The crown was dislodged by poking a needle on the skin outside of where the crown was stuck.The oad was safely removed, and the procedure was completed with balloon angioplasty.There was no damage to vessel.The patient was stable.

Manufacturer Narrative

The oad was returned to abbott without the guide wire.There was no damage or abnormalities observed with the oad driveshaft or handle assembly that would have contributed to the reported complaint.The crown diameter was measured and met specification.Scanning electron microscopic (sem) analysis of the driveshaft tip bushing identified evidence of rotational deposits of radiopaque material on the inside diameter of the tip bushing.This shows that the spinning driveshaft made contact with the guide wire spring tip.This is consistent with complaint details which state "treatment started but the scrub technician inadvertently pulled back the viperwire and spun over the viperwire tip resulting in the oad getting stuck." the root cause of the failure was considered to be use not consistent with the instructions for use (ifu) user manual.The diamondback 360 peripheral orbital atherectomy system (oas) ifu (92-100017 rev.C) warns: never advance the orbiting crown to the point of contact with the guide wire spring tip or other distal device.The maximum travel of the crown advancer knob - and therefore the shaft tip - is 15 cm.Moving the crown advancer knob forward moves the shaft tip an equal distance toward the guide wire spring tip.When moving the crown advancer knob, make sure there is sufficient distance between the guide wire spring tip (or other distal device) and the distal end of the shaft (10 cm minimum).If the distance between the shaft tip and the guide wire spring tip (or other distal device) is insufficient, the shaft tip may damage the guide wire spring tip.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 ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC. (ABBOTT); 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: lalaine oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 18653129
• MDR Text Key: 334690353
• Report Number: 3004742232-2024-00100
• Device Sequence Number: 1
• Product Code: MCW
• 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,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-150CLASS145
• Device Lot Number: 494326-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2023
• 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: 68 YR
• Patient Sex: Female
• Patient Weight: 170 KG