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

Model Number DBP-125MICRO145

Device Problem Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/31/2021

Event Type  Injury  

Manufacturer Narrative

The reported oad and wire used during the procedure were returned to csi for analysis.The oad driveshaft was damaged, deformed and cut and the distal driveshaft section and crown were not returned.The guide wire was destructively cut.The damage observed on the driveshaft and guide wire were determined to be due to handling and removal attempts.A review of the device data log showed that 17 of the 18 attempts to operate the oad resulted in a stall condition.It is possible that these stall events contributed to the reported event, however this could not be confirmed.When tested, the oad was found to have spun during all three speeds and functioned as intended.At the conclusion of the device analysis investigation the report that the oad became stuck in the vessel was not confirmed due to the condition of the returned device.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 prior to distribution.(b)(4).

Event Description

The diamondback peripheral orbital atherectomy device (oad) became stuck in a bend in the severely calcified and tortuous 1.5-2 mm pedal loop.Glideassist was activated in an attempt to remove the device, followed by pulling on the device while it was spinning.The oad was unable to be removed.The sheath of the oad was cut in an attempt to advance it over the crown, however this was not successful.The patient was transferred to surgery and a below the knee amputation was performed.The patient was in stable condition.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 11724723
• MDR Text Key: 247287758
• Report Number: 3004742232-2021-00154
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)221031(10)349372-1
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: DBP-125MICRO145
• Device Catalogue Number: 7-10057-01
• Device Lot Number: 349372-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2021
• 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; Disability
• Patient Weight: 181