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

Model Number DBP-125SOLID145

Device Problem Entrapment of Device (1212)

Patient Problem Perforation of Vessels (2135)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The diamondback peripheral orbital atherectomy device (oad) was used to treat a heavily calcified lesion in the anterior tibial artery.In the middle of the first treatment, which was low-speed, the oad became stuck, and a perforation occurred.The oad was removed, and the perforation was controlled with application of an angioplasty balloon.There was a delay of 30 minutes or more due to the issues experienced.The patient was stable and well following the procedure.The physician remarked that the crown felt hot to the touch when it was tested ex vivo.

Manufacturer Narrative

Device analysis conclusion: the oad was received at csi for analysis.Visual examination revealed adhered biological material on the driveshaft and crown.Microscopic and scanning electron microscopy analysis did not reveal any damage that would have contributed to the reported complaint.The device data revealed a stall condition at low speed.It is possible the stall condition occurred at the time of the reported device becoming stuck in the vessel.However, this could not be confirmed during failure analysis.There were no failures observed with the oad, and it spun as expected.The cause of the reported complaint is unknown.At the conclusion of the failure analysis investigation the reported stuck device issue and perforation could not be confirmed.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 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul, mn
• MDR Report Key: 10129100
• MDR Text Key: 194347025
• Report Number: 3004742232-2020-00161
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)220228(10)311200
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: 7-10057-02
• Device Lot Number: 311200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Date Manufacturer Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 111