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

Model Number DBP-125MICRO60

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 06/09/2020

Event Type  Injury  

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 Description

During a procedure with a diamondback peripheral orbital atherectomy device (oad), a vessel perforation occurred, and a subsequent stent was deployed.

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
• Type of Device: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.,; 1225 old highway 8 nw; saint paul, mn
• MDR Report Key: 10248670
• MDR Text Key: 198090962
• Report Number: 3004742232-2020-00179
• Device Sequence Number: 1
• Product Code: MCW
• UDI-Device Identifier: 10852528005206
• UDI-Public: (01)10852528005206(17)211130(10)298754
• Combination Product (y/n): N
• PMA/PMN Number: K190634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 08/04/2020
• Supplement Dates FDA Received: 08/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention