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

Model Number	GWC-12325LG-FLP
Medical Device Problem Codes	Off-Label Use (1494); Material Separation (1562); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during percutaneous coronary intervention (pci) of a calcified lateral obtuse marginal artery, proximal to stent, the vessel was primarily wired with a viperwire advance coronary guidewire as a buddy wire over a prior non-abbott guidewire which was later removed.The wire tip sheared off during a left heart catheterization (lhc), during removal after passing slightly into stent stenosed area.It was noted that there was a prior stent and orbital atherectomy into the proximal portion of prior stent.Three treatments at low-speed and two treatments at high speed were performed.It was presumed that as atherectomy was performed into the stent, the guidewire could have been compressed between the prior stent strut and the oad.The spring tip of the guidewire was left in-vivo in lateral obtuse marginal (om) which was a small branch.The tip of the wire was tacked with a new stent proximal to previous stent.The stent was placed past om, in om3 and across it with three total stent with visualization that it was outside the stent struts.The patient was monitored overnight and discharged the next day.The patient was stable.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
A visual inspection, dimensional analysis and detailed analysis were performed on the returned device.The reported guide wire fracture is confirmed.The reported device damaged by another device, off-label use - operated in a stent, unexpected medical intervention, foreign body in patient, and hospitalization are part of the reported complaint details are not able to be confirmed due to their operational context.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 guide wire fracture appears to be related to user error.Detailed analysis of the guide wire fracture face shows evidence of ductile torsion.It was reported that the guide wire spring tip sheared off during removal after passing slightly into stent stenosed area.It was noted that there was a prior stent and orbital atherectomy into the proximal portion of prior stent.The physician was aware of the stent prior to the procedure and the physician intentionally spun in stent.It should be noted that the diamondback 360 precision coronary orbital atherectomy system instruction for use (ifu) 92-10046-01 revision b, in the contraindications section, states: ¿use of the oas is contraindicated for use in the following situations: the target lesion is within a bypass graft or stent.¿ 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: d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: a2, a3, a4, a5, b7.
Event or Problem Description
It was reported that during percutaneous coronary intervention (pci) of a calcified lateral obtuse marginal artery, proximal to stent, the vessel was primarily wired with a viperwire advance coronary guidewire as a buddy wire over a prior non-abbott guidewire which was later removed.The wire tip sheared off during a left heart catheterization (lhc), during removal after passing slightly into stent stenosed area.It was noted that there was a prior stent and orbital atherectomy into the proximal portion of prior stent.Three treatments at low-speed and two treatments at high speed were performed.It was presumed that as atherectomy was performed into the stent, the guidewire could have been compressed between the prior stent strut and the oad.The spring tip of the guidewire was left in-vivo in lateral obtuse marginal (om) which was a small branch.The tip of the wire was tacked with a new stent proximal to previous stent.The stent was placed past om, in om3 and across it with three total stent with visualization that it was outside the stent struts.The patient was monitored overnight and discharged the next day.The patient was stable.

• 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: 22385090
• Report Number: 3004742232-2025-00189
• Device Sequence Number: 7138722
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)260630(10)8689726
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 08/19/2025

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: 06/30/2026
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: 72010-01
• Device Lot Number: 8689726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2024
• 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: Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Patient Race: White