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

Model Number DBP-200SOLID145

Device Problem Entrapment of Device (1212)

Patient Problem Vascular Dissection (3160)

Event Date 11/02/2021

Event Type  Injury  

Event Description

Following treatment of the right superficial femoral artery (sfa) with a diamondback peripheral orbital atherectomy device (oad), the physician retracted the device for removal.Resistance was encountered during removal, and the oad could not be retracted completely.The crown was advanced to relieve the resistance.Fluoroscopy was then used during continued attempts to retract the device.The crown was retracted and became entrapped in the distal portion of the insertion sheath.A technician pulled on the device to bring it back, and the physician pulled on the driveshaft.The oad then came free and was extracted from the patient.However, a 15cm portion of the driveshaft and crown remained in the distal portion of the sheath.The fragment protruded from the hub of the sheath.The physician pulled the fragment out.Angiogram then revealed a type c dissection in the sfa.The dissection was in the area of atherectomy treatment.The procedure was completed and the dissection was resolved with pre-planned angioplasty and stent placement.The patient was stable.

Manufacturer Narrative

Device analysis conclusion: the oad was returned to csi for analysis.Visual examination confirmed the reported driveshaft fracture.There was no other damage observed with the driveshaft crown or handle assembly that would have contributed to the reported events.Scanning electron microscopy analysis of the fractured filars shows evidence of fatigue, which is an indication that the driveshaft was spun in a high stress environment.Review of the device data log shows a stall event at the end of the procedure.It is unknown if the stall event occurred during an attempt to remove the device through the sheath or if the stall occurred during the treatment prior to removal.If the device was spun while pulling back through the sheath, this could have led to a stall and an elevated stress condition on the driveshaft, which may have contributed to the fracture.However, this could not be confirmed, and the exact cause of the fracture remains unknown.The report that the device was stuck in the introducer and the report that a dissection occurred could not be confirmed through analysis.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 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: 12900545
• MDR Text Key: 286340732
• Report Number: 3004742232-2021-00403
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10850000491202
• UDI-Public: (01)10850000491202(17)230131(10)364356-1
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: DBP-200SOLID145
• Device Catalogue Number: 7-10057-04
• Device Lot Number: 364356-1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2021
• 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
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Hispanic