MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK CORONARY; CATHETER, CORONARY, ATHERECTOMY

Model Number GWC-12325LG-FT

Device Problems Material Fragmentation (1261); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2020

Event Type  malfunction  

Event Description

Patient had a recent stemi (st wave-elevation myocardial infarction), status post pci (peri-cardial infarction) to the rca (right coronary artery) with a residual calcified lad (left anterior descending) lesion.Excerpts from cardiologist's ccl (cardiac cath lab) report: patient was brought in catheterization lab and was prepped and draped in sterile fashion.Access to right radial artery was obtained following placement of a 5-french terumo sheath.A runthrough wire was advanced into the diagonal branch and a flex tip wire from the csi company was wired straight into the mid lad.After that on the flex tip wire, i advanced the csi and was able to do 3 passes without difficulty or any problem.However, i noticed as i was trying to adjust the wire after the third pass that the wire was not responding to manipulation anymore.I started pulling the wire noticing that the tip was not moving, which confirmed to me that the tip has been severed from the body over the wire.The csi crown was also removed.At this point, i started to think of what the best way to do to snare this wire.Initially, i attempted to take a snare to the wire.However, the snare would not pass beyond the tight proximal lesion, so i decided then since i already did orbital atherectomy of the lesion, i should be able to stent it.So, i took a 3 x 8 compliant balloon to predilate so i can pass the snare without success.I then exchanged for a 3 x 8 noncompliant balloon and the balloon did not even yield at all forming a dog bone consistent with heavily calcified lesion despite using csi 3 times across the lesion.Of course, without being able to open the lesion, i would not be able to pass the snare.So, at this point, i decided to stop and removed the catheters and wires and then i discussed the case with cardiothoracic surgeon as the next step would be to perform a bypass to the diagonal and the lad and snare the wire intraoperatively.Excerpts from cardiothoracic surgery operative report: the patient was subsequently referred for possible coronary artery bypass grafting.The manufacture of the wire was called by cardiologist, who reported that the wire itself was not too thrombogenic.The left anterior descending artery was also identified.It was noted to have disease proximally.It was deemed suitable for grafting in its midportion.The proximal part of the lad was heavily calcified.The wire itself could not be palpated.The artery was opened and the wire was initially not seen.Careful examination revealed the wire was stuck to the sidewall.The end of it seemed to have dissected the lad and was stuck within the wall of the lad itself.The wire fragment was then removed without complication, in one piece.This was sent to pathology.Manufacturer response for coronary guide wire (viperwire advance with flex tip), csi viperwire advance with flex tip (per site reporter).Cardiologist called manufacturer about the device and was told that the wire was not too thrombogenic.Ccl manager also informed manufacturer.Retrieved wire was sent to pathology per protocol.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• MDR Report Key: 10249960
• MDR Text Key: 198103487
• Report Number: 10249960
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2020,07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWC-12325LG-FT
• Device Catalogue Number: 7-10038-01
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 68