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

Model Number DBP-125SOLID145

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

Estimated weight.Device analysis conclusion: the oad was returned for analysis with the guide wire.Visual examination confirmed the reported driveshaft fracture.The saline sheath was also separated, which is likely due to the fractured driveshaft having been spun within the sheath.The returned support catheter was inadvertently discarded during analysis.Scanning electron microscopy analysis of the fractured filars shows evidence of fatigue, which is an indication that the driveshaft was spun in a high stress environment.This is consistent with complaint details which state that the iliac vessels were very tortuous as well as stented bilaterally.This may have created a high-stress environment that contributed to fatigue.However, this could not be confirmed through analysis, and the root cause of the damage remains undetermined.Review of the device data log shows three stall events.It is unknown if the stall event occurred due to the crown becoming stuck or from interaction between the fracture and the saline sheath and/or wire.Csi id: (b)(4).

Event Description

A diamondback peripheral orbital atherectomy device (oad) was used via left femoral access and contralateral approach for treatment of a chronic total occlusion in the right superficial femoral artery (sfa).The vessel diameter was thought to be 6.0mm.Calcium was severe.One treatment was performed on low speed, and one treatment pass was performed on medium speed.Both treatments were performed distal to proximal.These treatments were performed in the proximal sfa.The device was advanced to the mid sfa for further treatment.One treatment pass was performed on low speed, and one treatment pass was performed on medium speed.Both treatments were distal to proximal.The physician then activated the oad for another treatment, but an unexpected "squeal" sound was observed.The physician then deactivated the device.The wire was then determined to be stuck in a side branch.The oad fractured.A support catheter, which was already in use, was used to remove the oad fragment.The wire was also freed the procedure was completed with angioplasty and stent placement.

• Brand Name: DIAMONDBACK 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 13411872
• MDR Text Key: 290691112
• Report Number: 3004742232-2022-00023
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)230331(10)372510-1
• 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: 02/01/2022

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 Expiration Date: 03/31/2023
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 372510-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2021
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White