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

Model Number	DBP-125SOLID145
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Noise, Audible (3273); Unexpected Shutdown (4019)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/17/2025
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.
Event or Problem Description
The diamondback 360 peripheral orbital atherectomy device (oad) was used for treatment of lesion in anterior tibial artery (at) via pedal access.During the first treatment, low speed was used but an audible pitch change was heard from normal grinding to the oad crown seemingly getting stuck which caused it to decelerate so it was turned off to stop the crown from spinning.The oad led lights remained lit.The oad was removed.There was no oad damage or tissue observed on the crown upon removal.The.014 viperwire advance peripheral guide wire with flex tip remained in place.Angiographic images showed perforation in at.In the opinion of the physician the oad caused the perforation due to the viperwire going subintimal without him realizing it.There is no allegation of device malfunction.To resolve the perforation, a jade balloon was inflated in the lesion for five minutes.The procedure was aborted.The patient was stable after the procedure and discharged the same day to be brought back in six weeks to continue treatment.
Additional Manufacturer Narrative
The device was not returned for analysis.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 information received, the investigation determined that the reported perforation of vessels, unexpected shutdown, and audible noise resulting in unexpected medical intervention appears to be related to unintended user error.In this case it is likely that the reported perforation of vessels, unexpected shutdown and audible noise resulting in unexpected medical intervention was due to device placement or use techniques employed.Per the physician's opinion, "the oad caused the perforation due to the viperwire going subintimal without him realizing it." 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.
Event or Problem Description
The diamondback 360 peripheral orbital atherectomy device (oad) was used for treatment of lesion in anterior tibial artery (at) via pedal access.During the first treatment, low speed was used but an audible pitch change was heard from normal grinding to the oad crown seemingly getting stuck which caused it to decelerate so it was turned off to stop the crown from spinning.The oad led lights remained lit.The oad was removed.There was no oad damage or tissue observed on the crown upon removal.The.014 viperwire advance peripheral guide wire with flex tip remained in place.Angiographic images showed perforation in at.In the opinion of the physician the oad caused the perforation due to the viperwire going subintimal without him realizing it.There is no allegation of device malfunction.To resolve the perforation, a jade balloon was inflated in the lesion for five minutes.The procedure was aborted.The patient was stable after the procedure and discharged the same day to be brought back in six weeks to continue treatment.

• Brand Name: DIAMONDBACK PERIPHERAL
• Common Device Name: CATHETER, PERIPHERAL, 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: 21335308
• Report Number: 3004742232-2025-00031
• Device Sequence Number: 8549899
• Product Code: MCW
• UDI-Device Identifier: 10850000491189
• UDI-Public: (01)10850000491189(17)250228(10)474013-1
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K220568
• 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): 05/05/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: DBP-125SOLID145
• Device Catalogue Number: DBP-125SOLID145
• Device Lot Number: 474013-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/08/2023
• 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
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White