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

Model Number	DBP-125MICRO145
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/31/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 11724723
• Report Number: 3004742232-2021-00154
• Device Sequence Number: 3549968
• Product Code: MCW
• UDI-Device Identifier: 10850000491172
• UDI-Public: (01)10850000491172(17)221031(10)349372-1
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Weight: 181