MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS, INC. DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM; PERIPHERAL ATHERECTOMY DEVICE

Model Number	PRD-SC30-150
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date received by manufacturer: the original event information was received on (b)(6) 2018.Information which caused the event to be considered reportable was received on (b)(6) 2018.Analysis of the reported device is in progress.A supplemental report will be submitted when the device analysis is completed.(b)(4).
Event or Problem Description
Resistance was encountered, and the guide wire could not be advanced through the peripheral stealth orbital atherectomy device (oad).The brake was lifted, but the issue persisted.A second oad was used to complete the procedure with a minimal delay of one to two minutes.The patient was well following the procedure.Information was received on (b)(6) 2018 that, during the reported event, the viperslide fluid did not exit the tip of the oad either.
Additional Manufacturer Narrative
Correction: previous follow-up (for correction to h10) report was inadvertently filed under the incorrect fda registration number.The report was filed under report number "3004742-2018-00271," but should have been filed under 3004742232-2018-00271.Device evaluation conclusion: the device was received at csi for analysis.A guide wire was passed through the device, but resistance was encountered in the brake assembly.Fluid flow was observed through the saline sheath as expected.Analysis of the brake assembly revealed an indentation on the spring landing of the brake plunger.This is consistent with the spring having been pinned between the brake halves, likely during assembly, which may not allow the spring to open the brake plunger.At the conclusion of the failure analysis investigation the reported event was confirmed.Csi id: (b)(4).
Additional Manufacturer Narrative
Correction to mfr number.

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS, INC.; 1225 old hwy 8 nw; st. paul MN 55112
• Manufacturer Contact: morgan hill ; 1225 old hwy 8 nw; st. paul, MN 55112
• MDR Report Key: 7840992
• Report Number: 3004742232-2018-00271
• Device Sequence Number: 1444972
• Product Code: MCW
• UDI-Device Identifier: 10852528005046
• UDI-Public: (01)10852528005046(17)210430(10)223545
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: PRD-SC30-150
• Device Catalogue Number: 70056-04
• Device Lot Number: 223545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 09/26/2018; 07/05/2023
• Initial Report FDA Received Date: 09/03/2018
• Supplement Report FDA Received Date: 07/05/2023; 10/01/2018
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2018
• 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
• Patient Sex: Unknown