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

Model Number GWC-12325LG-FLP

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

Device analysis: both guide wires were returned for analysis.The original oad and saline line were not returned for analysis.The initial visual examination of the guide wire related to the kink revealed that the spring tip coils were slightly deformed and unraveled near the proximal solder bond.The proximal solder bond remained intact and undamaged.Further examination revealed a kink in the guide wire 173.0cm distal to the proximal end.No biological material was observed on the guide wire.The initial visual examination of the guide wire that had broken off revealed that the spring tip was detached and missing.The diameter of the fractured section was measured with an in-house snap gauge and indicated that the fracture occurred in the tapered section of the guide wire.It is estimated that the fracture occurred between 4.2cm and 1.2cm from the distal end of the spring tip.The fractured section of the guide wire was destructively cut and sent for scanning electron microscope (sem) analysis.Sem analysis revealed torsional shear dimples on the face of the fracture, and rotational scoring damage on the shaft.No biological material was observed on the guide wire.The material inspection report for the guide wire lot numbers has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.At the conclusion of the failure analysis investigation the root cause of the kinked guide wire could not be determined.The root cause of the fractured guide wire also could not be determined.Sem analysis of the guide wire fracture face revealed torsional shear dimples.This indicates that the guide wire core underwent a torsional fracture.Rotational scoring was also present on the core wire near the fracture.Bench top testing has been able to recreate this damage by spinning the oad over a guide wire spring tip.As the original oad and the fractured distal portion of the guide wire and spring tip were not returned for analysis, the exact cause of the spring tip and guide wire section separating from the wire is unknown.(b)(4).

Event Description

It was reported that during a coronary orbital atherectomy procedure, the tip of a csi viperwire guide wire broke off and was left in the patient.The target lesion was 80% stenotic and was located in the right coronary artery (rca).The first csi guide wire got kinked during set-up, so a second guide wire was used for the procedure.A 6fr guide catheter was used to access the lesion and was then exchanged for the csi viperwire guide wire.A csi orbital atherectomy device (oad) was loaded onto the guide wire and advanced to the treatment site.The physician performed three runs at low speed using the oad.The oad was removed and a balloon was advanced over the viperwire to perform balloon angioplasty and complete the intervention.The balloon was removed from the patient and then the viperwire was removed from the patient.At this point, the physician noted that the tip of the viperwire had broken off and remained in the patient.The tip of the viperwire was left in the patient, but no patient complications were noted during the procedure.The patient status remained stable throughout the intervention.Requests for additional information have been made, but none has yet been received.

• Brand Name: DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM
• Type of Device: CORONARY 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: 5337873
• MDR Text Key: 34760109
• Report Number: 3004742232-2015-00095
• 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
• Type of Report: Initial
• Report Date: 12/29/2015

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?: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other