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

Model Number DBEC-125

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

Patient Problems Extravasation (1842); Perforation of Vessels (2135)

Event Date 10/24/2019

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 prior to distribution.(b)(4).

Event Description

Following treatment of an 80% stenosed lesion in a non-tortuous mid diagonal artery with two passes of a diamondback coronary orbital atherectomy device (oad), imaging was performed and a cloud of dye was observed which suggested a perforation had occurred.Balloon inflation was performed for several minutes and a stent was placed in the diagonal.It appeared the perforation had been resolved, however the septal branch of the diagonal was now jailed and shut down.A balloon was inserted through the struts of the stent into the septal branch to re-open it.After the inflation, an angiogram was performed and the perforation was noted again in the area of oad treatment.An embolization coil was placed in the septal branch to seal the perforation.The patient then became hypotensive, was treated pharmacologically and transferred to intensive care.The patient was stable several hours after the procedure.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• Manufacturer Contact: laramie otto ; 1225 old highway 8 nw; st. paul, mn, MN 55112 ; 6512591600
• MDR Report Key: 9330358
• MDR Text Key: 166630514
• Report Number: 3004742232-2019-00283
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)210731(10)281145
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2019

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: 07/31/2021
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 281145
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2019
• 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: 74 YR