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

Model Number	DBP-EX-150SOL145
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Return of the device for analysis is anticipated.If the device is received for analysis, a supplemental report will be submitted when the device analysis is completed.
Event or Problem Description
During removal of a diamondback peripheral exchangeable orbital atherectomy device (oad) the device became stuck in the sheath.The oad was pulled and the crown broke off inside the sheath.The crown fragment remained in the sheath and a sheath exchange was performed without losing wire position.
Additional Manufacturer Narrative
The reported oad was received at csi for analysis.The driveshaft crown was observed to be detached and was not returned for analysis.Scanning electron microscopy analysis of the driveshaft crown bond location was performed and confirmed the presence of residual solder, indicating that the crown had been sufficiently attached at one point.It is hypothesized that the crown became caught and the driveshaft was pulled until the crown bond strength was exceeded.This is consistent with the reported event details which state, "the device became stuck inside the sheath.The oad was pulled and the crown broke off inside the sheath.Per the physician, there may have been a kink in the sheath which contributed to the issue." however, this was not confirmed and the root cause of the detached crown remains unknown.Csi id: (b)(4).

• Brand Name: DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
• Common Device Name: PERIPHERAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS, INC.; 1225 old highway 8 nw; st. paul, mn MN 55112
• MDR Report Key: 12594262
• Report Number: 3004742232-2021-00338
• Device Sequence Number: 11857069
• Product Code: MCW
• UDI-Device Identifier: 10852528005831
• UDI-Public: (01)10852528005831(17)230831(10)393117
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190634
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2021

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: 08/31/2023
• Device Model Number: DBP-EX-150SOL145
• Device Catalogue Number: 7-10030-03
• Device Lot Number: 393117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 10/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR