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

Model Number	DBP-EX-125MIC145
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The oad was returned to csi for analysis with the guide wire engaged to the device.Visual examination confirmed the reported driveshaft fracture and stretching.The guide wire was also fractured; the distal spring tip fragment was not returned for analysis.Review of the device data log identified numerous stall events.The relation between the stalls and the fracture 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).
Event or Problem Description
A diamondback 360 exchangeable orbital atherectomy device (oad) was used for treatment distal to proximal in the pedal loop in four main lesions.A lesion in the mid pedal arch was long and diffusely diseased.The vessels were more than 90% stenosed and severely calcified.The diameter ranged from 2.5mm to 3.5mm in the successfully treated lesions and about 2 mm where the oad stopped spinning.The oad was advanced from the ostium to the posterior tibial (pt) artery, and lateral to the pt.From the posterior tibial (pt) artery to the ankle treatment was performed on medium speed.Treatment was performed on low speed below the ankle.Approximately 3cm into the pedal arch the device stopped spinning.Glideassist was activated, but the attempt to remove the device was unsuccessful.Excessive force was used to pull on the driveshaft and it fractured.The driveshaft became uncoiled from the pedal arch to the distal pt.The saline sheath became loose and was ex vivo.Unsuccessful attempts were made to snare the fragment and to dislodge the crown.The balloon was advanced crossing from the anterior tibial (at) artery to the pedal loop.Revascularization was performed using balloon angioplasty.The patient was stable, and the procedure was completed.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: 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: kim mcclure ; 1225 old hwy 8 nw; st. paul, MN 55112 ; 6519006741
• MDR Report Key: 14734848
• Report Number: 3004742232-2022-00138
• Device Sequence Number: 5583020
• Product Code: MCW
• UDI-Device Identifier: 10852528005817
• UDI-Public: (01)10852528005817(17)240331(10)427828
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

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: 03/31/2024
• Device Model Number: DBP-EX-125MIC145
• Device Catalogue Number: 7-10030-01
• Device Lot Number: 427828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2022
• Initial Report FDA Received Date: 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 54 KG