MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	OFG2524LF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was returned for analysis.As reported by the customer: 'the catheter never approached the tip of the wire.There was resistance when removing the phoenix but was removed successfully.An.014 sleek balloon was advanced to the same area and was not able to cross the wire area in question.The wire and balloon were then removed as an assembly and the wire remained in the balloon that has also been provided'.Additionally, the photos were provided where the distal end of the guidewire was protruding from the catheter.Cannot determine from the photos that it is a fracture shear, but there is evidence of multiple bends on the distal region of the guidewire.This could indicate that some force may have been applied to that section, which could have led to the damage in the form of bends.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided by the supporting documentation, "inexperienced user", "operational context", "improper use", "excessive force" , "improper removal from packaging", "improper handling", "user failure in preparation for use" and/or "unanticipated user error" appears to have impacted on the event as reported.
Event or Problem Description
We had a case of wire failure when using the 1.8 phoenix.We used the phoenix floppy wire.The wire was retrieved the patient is fine.Wire and catheter were in the left pt.As you can see from the images the catheter never approached the tip of the wire.There was resistance when removing the phoenix but was removed successfully.An.014 sleek balloon was advanced to the same area and was not able to cross the wire area in question.The wire and balloon were then removed as an assembly and the wire remained in the balloon that has also been provided.There wire brake was functional and there was no issues at prep.The wire was new and had been exchanged for the original pt choice wire that had been used to cannulate the vessel.At some point there had been friction that had created that had worn an area of the distal end of the wire.The phoenix catheter complaint (b)(4) was opened concomitant to this complaint (b)(4).(phoenix 1.8mm x 130 cm catheter, p18130k lot number 11052002-039.Patient was discharged as planned; ambulatory and in good condition.Date of occurrence: (b)(6) 2020 date of awareness: (b)(6) 2021 (that guidewire may have caused or contributed to dissection).Additional patient details are below please clarify "wire stick" are you referencing initial vascular access or do you mean there was a dissection caused by the phoenix wire? the wire appeared to be stuck in a sub-intimal plane.Don't know if the wire caused this or not.What device caused the dissection?[?]again the wire appeared to stick? the 1.8 was removed but when the balloon advanced it stuck to the wire and was removed as an assembly.What devices were in the patient at the time of the dissection? the cordis savvy balloon and the phoenix floppy wire.How was the dissection resolved? the dissection showed now significant extravization and it was left with no further intervention.I am unclear, is there an allegation the wire was damaged or separated? (please be specific) the wire was damaged and remained in the lumen of the balloon when it was pulled out.Access location? ipsilateral antegrade.Vessel tortuosity? very little.Was this a peripheral or coronary procedure? peripheral.Was the procedure itself for diagnostic or therapeutic purposes? therapeutic was procedure completed with suspect device? no.How was the procedure completed? attempted angioplasty.What was the outcome of the procedure? patient was fine.Was physical damage to the device observed? to the wire ? yes, the wire was stuck in the lumen of the balloon.Did an embolization occur? negative.Was any additional unscheduled intervention required to remove the device? none was any damage observed on the device after removal from the patient? the wire stayed in the lumen of the balloon.Were any protruding parts observed after removal? the wire remained the balloon lumen.Was the device inspected when removed from packaging for visual damage? yes.Was any damage observed during prep? none.How many times had the device been inserted into the patient? once.What other devices were being used at the same time as this device? the phoenix, then the balloon.(introducer, guide catheter, guide wire, stent, other?) please provide the manufacturer, device name, and device description for each of these devices.Was vessel full occluded? above 60%.Target lesion % occlusion at time of crossing? above 60%.Was guidewire advanced ahead of catheter when crossing lesion? yes.If peripheral, was the catheter tracked over-the-horn? no- ipsilateral antegrade.Was the patient discharged as expected? yes.In what condition? ambulatory and in good condition.Stuck and wire stick means the wire was stuck to the balloon.Not the vessel.The wire was maintaining position and could have been subintimal without the physician appreciating its position.When noting the dissection, was vessel spasm recognized distally under fluoro? there could have been sum amount but this wasn't evaluated with nitro.Was the atherectomy portion of the procedure completed prior to the dissection? most of it.

• Brand Name: PHOENIX GUIDEWIRE
• Common Device Name: GUIDEWIRE
• Manufacturer (Section D): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, Y34 K 825; EI Y34 K825
• MDR Report Key: 11653531
• Report Number: 9681477-2021-00005
• Device Sequence Number: 14326875
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)201210(10)10935428
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K080144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2020
• Device Model Number: OFG2524LF
• Device Catalogue Number: PG14300LF
• Device Lot Number: 10935428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other