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

Model Number GWC12325LGFT

Patient Problems Calcium Deposits/Calcification (1758); Pain (1994); Discomfort (2330)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Following diagnostic catheterization, intervention was undertaken on the mid lad (left anterior descending artery).Due to the tortuosity, length of lesion heavy calcification, atherectomy was performed utilizing a diamondback csi 1.25 bur.After 3 passes with the bur, the atherectomy device was removed and angiography revealed abrupt closure of the lad in the mid segment.The patient was experiencing chest discomfort.I therefore passed the first stent into the mid-lad covering the original lesion and deployed it.This restored timi i flow (thrombolysis in myocardial infarction) into the stented portion of the vessel, but still timi 0 flow down the lad.I passed a run-through wire beside the viper wire and then advanced the second stent using the viper wire as a buddy wire.Patient was having significant pain and i deployed the second stent jailing the viper wire.This restored timi-3 flow down the vessel.I went to withdraw the viper wire, but the wire was entrapped beneath the second stent.I advanced a turnpike catheter over the viper wire and applied constant pressure retracting though viper wire, but the weld between the wire and its tip, which was likely the point of entrapment fractured leaving the flexible tip behind the original stent.That original stent had collapsed most of the lumen as i withdrew the wire, and the stent foreshortened.At this point, call was placed to ct surgery.

• Brand Name: DIAMONDBACK CORONARY
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 14740 kirby dr; houston TX 77047
• MDR Report Key: 17833145
• MDR Text Key: 324480597
• Report Number: 17833145
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GWC12325LGFT
• Device Catalogue Number: 7-10038-01
• Device Lot Number: LOG7277942
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/22/2023
• Date Report to Manufacturer: 09/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Female
• Patient Weight: 136 KG
• Patient Race: White