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

Model Number	DBP-125MICRO60
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	06/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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 diamondback peripheral orbital atherectomy system instructions for use manual states that perforation is a potential adverse event, that may occur and/or require intervention.Additional event and patient information has been requested, but has not yet been received.If additional information is received, a supplemental report will be submitted.(b)(4).
Event or Problem Description
During a procedure with a diamondback peripheral orbital atherectomy device (oad), a vessel perforation occurred, and a subsequent stent was deployed.
Additional Manufacturer Narrative
The reported diamondback peripheral orbital atherectomy device (oad) was returned to csi for analysis.Visual examination of the oad revealed adhered material on the driveshaft and crown area.There was no damage observed that would have contributed to the accumulation, and the morphology and exact root cause of the accumulation was unknown.A guide wire was unable to pass through the area of adhered material on the driveshaft.When tested for functionality, the oad functioned as intended.At the conclusion of the device analysis, the reported event could not be confirmed.It could not be determined if the adhered biological material was related to the perforation event, and the cause of the perforation was unknown.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.H6 - 4247: biological material present on device.(b)(4).

• 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; saint paul, mn
• MDR Report Key: 10248670
• Report Number: 3004742232-2020-00179
• Device Sequence Number: 13601759
• Product Code: MCW
• UDI-Device Identifier: 10852528005206
• UDI-Public: (01)10852528005206(17)211130(10)298754
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: DBP-125MICRO60
• Device Catalogue Number: DBP-125MICRO60
• Device Lot Number: 298754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 07/08/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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