MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INC. DIAMOND BACK 360 ORBITAL ATHERECTOMY DEVICE; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number DBP-125MICRO145

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/30/2019

Event Type  Injury  

Event Description

Csi device lodged in the peroneal artery and unable to retrieve by endovascular and surgically.On (b)(6) 2019: attempted retrieval using snare: unsuccessful.On (b)(6) 2019, vascular surgery, popliteal.Endarterectomy and attempted retrieval of foreign body: unsuccessful.On (b)(6) 2019: posterior tibial to plantar by pass: clotted.On (b)(6) 2019: angiojet thrombectomy of clots in the affected leg, followed by catheter directed thrombolysis.On (b)(6) 2019: follow-up angiogram.

• Brand Name: DIAMOND BACK 360 ORBITAL ATHERECTOMY DEVICE
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INC.
• MDR Report Key: 8407631
• MDR Text Key: 138407992
• Report Number: MW5084792
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DBP-125MICRO145
• Device Lot Number: 249981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 43 YR
• Patient Weight: 94