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

Model Number DBEC-125

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Material Separation (1562); Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/04/2023

Event Type  Injury  

Manufacturer Narrative

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.The material inspection report for the reported guide wire could not be reviewed, as the lot number was not provided.The results of the investigation are inconclusive since the reported devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The coronary orbital atherectomy system (oas) ifu lists treatment of a lesion within a stent as a contraindication.Csi id: (b)(4).

Event Description

During treatment, the diamondback 360 coronary orbital atherectomy device (oad) stalled and got stuck in a coronary stent.The oad was removed but pulled the stent with it.The viperwire guide wire fractured but was successfully snared.The patient was stable.

Manufacturer Narrative

Csi id: (b)(4) (b)(4).

Event Description

During low-speed treatment of a heavily calcified, 95% occluded, 3mm-in-diameter lesion in the left anterior descending (lad) using the diamondback 360 coronary orbital atherectomy device (oad) via common femoral artery, the oad stalled coming back from the third or fourth treatment and got stuck in a coronary stent.The oad was removed but pulled the stent with it.The viperwire guide wire fractured and was successfully snared.Balloon angioplasty and stent application were performed post atherectomy as planned.The patient was stable.The physician does not believe they spun in the stent; however, this could not be confirmed.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY 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: 18016429
• MDR Text Key: 326677094
• Report Number: 3004742232-2023-00263
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850026568087
• UDI-Public: (01)10850026568087(17)250731(10)250731
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• 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: 11/17/2023

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
• Device Operator: Health Professional
• Device Model Number: DBEC-125
• Device Lot Number: 500837-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2023
• 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
• Treatment: VIPERWIRE GUIDEWIRE - LOT NUMBER UNKNOWN.
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 85 KG