MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY, CLASSIC, 135 CM; CATHETER, CORONARY, ATHERECTOMY

Model Number DBEC-125

Device Problems Break (1069); Material Separation (1562); Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944)

Patient Problems Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Thrombus (2101); Injury (2348)

Event Date 07/14/2020

Event Type  Injury  

Event Description

Under lidocaine 1% local anesthesia a 6 fr introducer was placed in the right radial artery using modified seldinger technique.The circumflex into om lesion was crossed using a 300 cm length pt moderate support wire.An attempt to advance a 1.25 otw balloon was not successful.A fine cross catheter was used to advance beyond the blockage.The long pt wire was exchanged to viper wire.The 1.25 tip orbital atherectomy device (csi) was advanced using the usual technique.Low speed orbital atherectomy was done at the proximal lesion, followed by distal om lesion.The burr advanced antegrade into the lesion.Upon performing the csi from the distal end into the proximal end of the distal lesion using low speed rpm, the device tip separated from shaft.Approximately 3-4 cm of the distal device broke off.A second wire was used to rewire the lesion.Under lidocaine 1% local anesthesia a 6 fr introducer was placed in the right femoral artery using modified seldinger technique.Several attempts were made to pull back the tip into the guiding catheter but were unsuccessful.This included inflating the balloon distal to the tip and pulling it back.Also included using balloon with ntg proximal to the tip and trying to pull back.Attempted to place a snare, but was unsuccessful.Patient eventually thrombosed the circumflex vessel.Wire and diamond back tip remain in the circumflex.Surgery was consulted but patient was not a surgical candidate.Under lidocaine 1% local anesthesia a 9 fr introducer was placed in the left femoral artery using modified seldinger technique.Iabp was inserted in the left femoral area.Impella cp was inserted in the right femoral area.Iabp removed from left femoral site.Full anti-coagulation started.Tr band deployed to right radial artery.10 ml air in band.Site stable.Right femoral sheath remains in place with impella device in place.Site stable.Left femoral sheath remains in place.Site stable.The patient suffered another myocardial infarction in the heart tissue fed by the left circumflex coronary artery and suffered acute kidney injury and profound hypotension the evening of the procedure.Patient discharged with ongoing care by cardiology.Note: when the device was retrieved from cath lab, all the parts were present but a foreign object was also found in the wrappings and a photo is included in this report.It is unknown if this was part of the device or something else.

• Brand Name: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY, CLASSIC, 135 CM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; saint paul MN 55112
• MDR Report Key: 10493421
• MDR Text Key: 205671596
• Report Number: 10493421
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005787
• UDI-Public: (01)10852528005787(17)220131(10)307433
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/03/2020

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?: Yes
• Device Operator: No Information
• Device Model Number: DBEC-125
• Device Catalogue Number: 70058-13
• Device Lot Number: 307433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28835 DA
• Patient Weight: 117