MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	OFG2525XF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product not yet received for analysis.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.However, the device was used past its expiry date 27 march 2021.The reported event date is 13 april 2021.
Event or Problem Description
The device was advanced to the lesion and when a second pass was required, the device was removed without incidence.Upon removal and correlated with x-ray, a small portion of the phoenix light support wire was noticed to have broken off and was in the lower leg.The broken segment was approximately 10 in long and was very noticeable.The surgeon advanced another wire down to the area and used a gooseneck snare to retrieve the segment of the phoenix wire.X-rays were used to confirm that all portions of the wire was removed.The patient's outcome was good.Additional information: the prep of both the phoenix wire and phoenix catheter were normal.No damage was observed prior to use.The devices had a little trouble at the lesion but were removed without incident.There were no other issues with the devices until reviewed under x-ray.Then it was noticed a portion of the distal tip was left in the patient.No unusual force was used on the devices and there was no difficulty advancing the devices.A gooseneck snare was used to remove the device.No other devices were used at the same time as the phoenix devices.The devices were shipped.The patient was discharged and is doing well.Monday afternoon is his meeting with the facility and will confirm the patient information requested.Was resistance encountered? no.Lesion calcification: severe.Type of "target" lesion: calcified.Was the device in one piece after removal from the patient? no access approach: contralateral.Chronic total occlusion (cto)? yes.Was the support clip used? (phoenix catheter) yes.Was the device flushed per the ifu? yes.
Event or Problem Description
The device was advanced to the lesion and when a second pass was required, the device was removed without incidence.Upon removal and correlated with x-ray, a small portion of the phoenix light support wire was noticed to have broken off and was in the lower leg.The broken segment was approximately 10 in long and was very noticeable.The surgeon advanced another wire down to the area and used a gooseneck snare to retrieve the segment of the phoenix wire.X-rays were used to confirm that all portions of the wire was removed.The patient's outcome was good.Additional information: the prep of both the phoenix wire and phoenix catheter were normal.No damage was observed prior to use.The devices had a little trouble at the lesion but were removed without incident.There were no other issues with the devices until reviewed under x-ray.Then it was noticed a portion of the distal tip was left in the patient.No unusual force was used on the devices and there was no difficulty advancing the devices.A gooseneck snare was used to remove the device.No other devices were used at the same time as the phoenix devices.The devices were shipped.The patient was discharged and is doing well.Monday afternoon is his meeting with the facility and will confirm the patient information requested.Was resistance encountered? no.Lesion calcification: severe.Type of "target" lesion: calcified.Was the device in one piece after removal from the patient? no.Access approach: contralateral.Chronic total occlusion (cto)? yes.Was the support clip used? (phoenix catheter) yes.Was the device flushed per the ifu? yes.
Additional Manufacturer Narrative
Updated with device evaluation.

• 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: 11822981
• Report Number: 9681477-2021-00008
• Device Sequence Number: 3909217
• Product Code: DQX
• UDI-Device Identifier: 10845225002746
• UDI-Public: (01)10845225002746(17)210327(10)10982265
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 06/24/2021

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: 03/27/2021
• Device Model Number: OFG2525XF
• Device Catalogue Number: PG14300XF
• Device Lot Number: 10982265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2021
• Initial Date Received by Manufacturer: 04/16/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHOENIX CATHETER SYSTEM, 2.2MM X 149CM, 6F P22149K.; PHOENIX CATHETER SYSTEM, 2.2MM X 149CM, 6F P22149K.
• Outcome Attributed to Adverse Event: Required Intervention