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

Model Number DBP-150SOLID145

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolism (1829); No Code Available (3191)

Event Date 09/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Failure analysis conclusion: the device was received at csi for investigation without the guide wire.Shipping damage was observed and removed to allow for functional testing.An in-house test wire was passed through the device without issue.There was no other damage observed with the oad.When tested, the device functioned as intended.At the conclusion of the failure analysis investigation the reported possible spasm and embolism were not confirmed.There was no damage or abnormalities observed with the oad or driveshaft that would have contributed to the reported complaint.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 diamondback360® peripheral orbital atherectomy system instructions for use manual states that distal embolization and vessel spasm are adverse events that can occur during use of the device.(b)(4).

Event Description

Atherectomy was performed on low, medium, and high speeds with a diamondback peripheral orbital atherectomy device.The treatments were performed in the popliteal artery.A stent was placed with good angiographic result.Imaging showed possible spasm and embolization in the posterior tibial (pt) artery.Attempts to rewire the vessel with a non-csi wire caused a complication in the pt artery.This complication was not caused by csi product.The complication was not treated; the patient was monitored.The patient had an observable pulse in the pt artery on ultrasound and was discharged on (b)(6) 2019.

• 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: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 9167518
• MDR Text Key: 166593870
• Report Number: 3004742232-2019-00263
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005237
• UDI-Public: (01)10852528005237(17)210630(10)276766
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: DBP-150SOLID145
• Device Catalogue Number: DBP-150SOLID145
• Device Lot Number: 276766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2019
• 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): Other
• Patient Age: 93 YR