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

Model Number DBP-150CLASS145

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2022

Event Type  malfunction  

Manufacturer Narrative

Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.Csi id: (b)(4).

Event Description

A diamondback 360 peripheral orbital atherectomy device (oad) was used to treat a 100% stenosed, heavily calcified, 3.5mm diameter anterior tibial artery.The oad could not cross the lesion.Force was applied which was successful and treatment was performed.Cinemograph imaging revealed a driveshaft fracture in the at.The fractured component was removed.The patient was stable.

Manufacturer Narrative

The oad was returned without the guidewire.Analysis revealed the crown to be detached and located proximal on the driveshaft.Foreign sheath tubing was observed on the driveshaft distal to the saline sheath.Scanning electron microscopic (sem) analysis of the crown identification and driveshaft crown bond revealed the presence of adequate solder residue.It was reported that the physician pushed the crown with force to cross a difficult lesion, though the root cause cannot 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)(6).

Manufacturer Narrative

The oad was returned without the guidewire.Analysis did not confirm the reported event of saline sheath damage.Analysis revealed the crown to be detached and located proximal on the driveshaft.Foreign sheath tubing was observed on the driveshaft distal to the saline sheath.Scanning electron microscopic (sem) analysis of the crown identification and driveshaft crown bond revealed the presence of adequate solder residue.It was reported that the physician pushed the crown with force to cross a difficult lesion, though the root cause cannot be determined.

• 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: 16070343
• MDR Text Key: 306357614
• Report Number: 3004742232-2022-00327
• 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,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-150CLASS145
• Device Catalogue Number: 7-10057-08
• Device Lot Number: 437255-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2022
• 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): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female