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

Model Number DBEC-125

Device Problems Unintended System Motion (1430); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

Device analysis is in progress.A supplemental report will be submitted when the investigation is complete.Csi id: (b)(4).

Event Description

Five low-speed treatments were performed in the left anterior descending (lad) artery with a diamondback 360 coronary orbital atherectomy device (oad).During the second low-speed treatment of a highly tortuous lesion in the circumflex (cx) artery from distal to proximal, the oad crown jumped and the driveshaft was observed to be fractured.The fractured component was snared.The oad and the viperwire advance coronary guide wire were replaced to complete the procedure.The patient was stable.

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 oad was returned to csi for analysis with the guide wire engaged.There was no evident damage to the core shaft or spring tip of the guide wire.A driveshaft fracture at the distal edge of the crown was observed.The fractured driveshaft sections were sent to scanning electron microscopic (sem) analysis.Sem analysis identified fatigue striations at the site of the driveshaft fracture.Although the exact root cause of this event is undetermined, it is hypothesized that the fatigue striations indicate the driveshaft underwent excessive flexing near the crown due to spinning in excessive tortuosity or resistance that pushed the driveshaft into a tight bend shape.During functional testing, the oad functioned as intended.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• 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: oria ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 17959895
• MDR Text Key: 325976247
• Report Number: 3004742232-2023-00248
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10850000491530
• UDI-Public: (01)10850000491530(17)240630(10)439065-1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

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: 439065-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/27/2023
• Supplement Dates FDA Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female