MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC AGILITY HYDROPHILIC STEERABLE GUIDEWIRES; CATHETER GUIDEWIRE

Catalog Number UNKAGILITY

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problems Chest Pain (1776); Pleural Effusion (2010)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

Concomitant products: 6f guide catheter, wingspan stent (stryker), 2.0 x 15mm gateway balloon (stryker), prowler 14 microcatheter (codman).Article attached: koo, h., wonhyoung, p, yang, k et all.2016.¿fracture and migration of a retained wire into the thoracic cavity after endovascular neurointervention: report of 2 cases¿.J neurosurg published online march 18, 2016; doi: 10.3171/2015.12.Jns152381.Since the catalog and lot number could not be obtained, the manufacturing and expiration dates are unknown.Three attempts to obtain additional information, including the date of the procedure, date of adverse event were unknown, and patient and device specific were unsuccessful.Conclusion: the device was not available for analysis.In addition, the lot number was not available; therefore, a review of manufacturing documentation could not be performed.Distal tip entrapment and separation are known events that can occur during use of the agility wire.Based on the information provided, the root cause of the event could not be determined; however, procedural factors (device interaction) may have contributed to the event.The instructions for use cautions: ¿to prevent vessel injury or tip entrapment, use fluoroscopy when advancing/torqueing the guidewire¿.The ifu also states ¿torqueing the guidewire against resistance may cause damage and /or fracture which may result in separation of the distal tip¿.There was no evidence the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

In the literature article entitled ¿fracture and migration of a retained wire into the thoracic cavity after endovascular neurointervention: report of 2 cases¿ by koo, hae-won, et.Al., it was reported that an agility 10 wire (catalog/lot unk) fractured and separated in the patient during an endovascular interventional procedure, and approximately 4 years later, the patient presented with a pneumothorax related to the retain portion of the wire migrating into the thoracic cavity.Per the article, the patient had presented with basilar artery stenosis and combined de novo thrombosis with brainstem ischemia.Emergency revascularization of the basilar artery was performed, and they were able to cross the occluded segment without difficulty.A 3.5 × 20¿ mm wingspan stent (stryker) was placed along the basilar trunk, covering both the stenosis and thrombotic filling defect after balloon angioplasty (2.0 × 15¿mm gateway balloon, stryker).Subsequent control angiography showed persistent narrowing of the distal basilar trunk due to residual thrombus in the basilar top.An agility 10 guidewire was used to navigate a prowler 14 infusion microcatheter into the basilar top for local fibrolytic therapy.However, the tip of the guidewire became entangled with one of the open-cell stent struts, and they were unable to untangle the knotted wire.They decided to leave the guidewire in situ and successfully used another one to deliver the microcatheter.Eventually, they were able to open the entire basilar artery and its branches, but could not retrieve the tangled guidewire.Various endovascular maneuvers were attempted to remove the wire, but none helped.Fortunately, the patient¿s degree of weakness improved significantly while the patient was on the operating table.The guidewire was then transected at the level of the femoral artery puncture point and anchored to the subcutaneous fascia layer with a small monofilament suture.The patient successfully recovered from the infarction and was discharged from the hospital 8 days after the initial symptom onset.The patient was informed about the retained guidewire, but was reassured that it was not a problem because he required dual antiplatelet therapy anyway.The patient underwent regular follow-up with chest radiography and head ct angiography on an annual basis.The stented basilar artery stayed open, the guidewire remained in the aorta, and the left vertebral artery did not show any change until the patient presented with unexplained chest pain 3.5 years after the procedure.A chest ct scan showed a curvilinear radiopaque structure over the apex of the right emphysematous lung, with one end of the structure at the anterior mediastinum and the other end at the posterior costophrenic angle, with minimal unilateral pleural effusion.Subsequent video-assistaed thoracoscopic surgery (vats) revealed a long guidewire fragment that was successfully removed by the local surgeon.The retrieved wire segment was about 85 cm long with a thin, silver shiny body surface that was different from that of the original wire.Follow-up ct angiography showed no change in the tangled guidewire in the patent stented segment, but the wire was broken at the c-4 vertebral body level.There was a residual line fragment on abdominal radiography.We believed that the long retained guidewire had fractured at the c-4 segment level and that the proximal body segment had migrated into the left thoracic cavity and had been removed completely.The patient recovered successfully without any sequelae.The patient is on a regimen of aspirin monotherapy at the present time.¿ the article did not provide the catalog and lot number of the agility wire.

• Brand Name: AGILITY HYDROPHILIC STEERABLE GUIDEWIRES
• Type of Device: CATHETER GUIDEWIRE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 5853149
• MDR Text Key: 51356890
• Report Number: 1226348-2016-00128
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K010511
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/15/2016

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAGILITY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2016
• Initial Date FDA Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR