MAUDE Adverse Event Report: CARDIOVASCULAR SYSTEMS INCORPORATED DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM; CORONARY ORBITAL ATHERECTOMY DEVICE

Model Number GWC-12325LG-FLP

Device Problem Material Fragmentation (1261)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Csi is awaiting the return of the wire for analysis.The facility is conducting their own internal analysis.(b)(4).

Event Description

It was reported that during a coronary orbital atherectomy procedure, the tip of a csi viperwire guidewire detached and was left in the patient.There were 2 target lesions located in the distal right coronary artery (rca).The distal lesion was crossed using the viperwire guidewire, which was advanced into the right posterior descending artery (pda).The physician started treatment using a csi orbital atherectomy device (oad) at the proximal edge of the lesion and advanced distally through the lesion.It was noted during treatment that the tip of the oad had briefly contacted the tip of the viperwire guidewire, but no problems were noted at that point.The physician completed three runs at low speed in the distal lesion and then retracted the oad to the proximal lesion.The proximal lesion was treated using three runs at low speed and one run at high speed.The oad was removed and atherectomy was followed-up with balloon angioplasty and stent placement over the viperwire.When the physician removed the viperwire, he discovered that the tip remained in the pda.After an unsuccessful removal attempt, the wire was left in the pda.The patient status remained stable throughout the procedure.Three requests for additional information have been made, but none has yet been received.A request to return the wire for analysis has also been made, but the wire has not yet been returned.

Manufacturer Narrative

(b)(4).Not returned to csi by facility.

Event Description

No additional information was received and the wire was not returned to csi for analysis.

• Brand Name: DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY ORBITAL ATHERECTOMY DEVICE
• Manufacturer (Section D): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer (Section G): CARDIOVASCULAR SYSTEMS INCORPORATED; 1225 old highway 8 nw; saint paul MN 55112
• Manufacturer Contact: megan brandt ; 1225 old hwy 8 nw; saint paul, MN 55112 ; 6512592805
• MDR Report Key: 5107539
• MDR Text Key: 26873552
• Report Number: 3004742232-2015-00066
• Device Sequence Number: 1
• Product Code: MCX
• UDI-Device Identifier: 10852528005183
• UDI-Public: (01)10852528005183(17)170131(10)10480018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 01/31/2017
• Device Model Number: GWC-12325LG-FLP
• Device Catalogue Number: GWC-12325LG-FLP
• Device Lot Number: 10480018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention