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

Model Number	GWC-12325LG-FLP
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The oad referenced in b5 are filed under separate medwatch report number.
Event or Problem Description
It was reported that a non-abbott guidewire was used to wire the left anterior descending (lad) artery.A teleport catheter was inserted to exchange for a viperwire coronary guidewire and a diamondback coronary orbital atherectomy device (oad) was advanced to the lesion.The tip of the shaft was advanced just before the lesion.Three treatments were performed on low speed were performed to treat the lesion.During removal of the oad, glide assist was activated and the device got stuck in the mid-shaft of the left main (lm).A ¿revving sound¿ was noted as the glide assist was failing and several attempts were made to re-engage glide assist but it could not stay on.The conventional removal method failed as the oad and guidewire could not move.The shaft and the guidewire were cut so that a guideliner could be advanced in an attempt to wrap the crown and remove the device.The crown and shaft were successfully removed but the tip of the viperwire guidewire dislodged and remained in the lad resulting in a dissection.Attempts were made to inflate a balloon and trap the tip with the help of a guidewire but was unsuccessful.A balloon was used the dissected lad was stented trapping the guidewire tip between the stent and the wall.A treatment with a non-abbott device of the lm was performed and a stent was placed there as well.This activity resulted in some erratic and unstable hemodynamic pressures.It was determined that a balloon pump would be inserted and the patient was intubated.Over the weekend the balloon pump was removed but the patient remained intubated.
Additional Manufacturer Narrative
A visual inspection, functional testing and dimensional analysis was performed on the returned device.The reported difficult to remove, material separation, hospitalization, vascular dissection, and unexpected medical intervention were not confirmed due to the operational context of the issues.Production record and corrective and preventative actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot specific issue.Based on the reported information and the observations from the returned analysis, the investigation determined that the reported difficult to remove, material separation, hospitalization, vascular dissection, and unexpected medical intervention appears to be related to circumstances of the procedure.The returned guide wire is cut with 178cm returned, engaged in the oad.The distal section was not returned for analysis.The guide wire was removed distally from the driveshaft with resistance due to shipping damage.There was no other damage observed.Based on the results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Updated fields: b5, b7, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h10, and h11 h10: oad mdr report number.
Event or Problem Description
It was reported that a non-abbott guidewire was used to wire the left anterior descending (lad) artery.A teleport catheter was inserted to exchange for a viperwire coronary guidewire and a diamondback coronary orbital atherectomy device (oad) was advanced to the lesion.The tip of the shaft was advanced just before the lesion.Three treatments were performed on low speed were performed to treat the lesion.During removal of the oad, glide assist was activated and the device got stuck in the mid-shaft of the left main (lm).A ¿revving sound¿ was noted as the glide assist was failing and several attempts were made to re-engage glide assist but it could not stay on.The conventional removal method failed as the oad and guidewire could not move.The shaft and the guidewire were cut so that a guideliner could be advanced in an attempt to wrap the crown and remove the device.The crown and shaft were successfully removed but the tip of the viperwire guidewire dislodged and remained in the lad resulting in a dissection.Attempts were made to inflate a balloon and trap the tip with the help of a guidewire but was unsuccessful.A balloon was used the dissected lad was stented trapping the guidewire tip between the stent and the wall.A treatment with a non-abbott device of the lm was performed and a stent was placed there as well.This activity resulted in some erratic and unstable hemodynamic pressures.It was determined that a balloon pump would be inserted and the patient was intubated.Over the weekend the balloon pump was removed but the patient remained intubated.

• Brand Name: DIAMONDBACK CORONARY
• Common Device Name: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED, #3004742232; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: alyssa mickelson ; 1225 old highway 8 nw; st. paul, MN 55112 ; 6517562718
• MDR Report Key: 22742604
• Report Number: 3004742232-2025-00229
• Device Sequence Number: 17962635
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)260131(10)8689722
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 8689722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male