MAUDE Adverse Event Report: LAKE REGION MEDICAL LIMITED PHOENIX GUIDEWIRE

Model Number	OFG2524LF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Nature of complaint: the atherectomy device as well as the guidewire was prepared as per indications in the ifu.The catheter was used successfully for approximately 5-6 back and forth runs.As the physician tried to remove the catheter over the guidewire, a big resistance was observed.The physician believed the guidewire was stuck in the catheter.The user turned the motor back on to ease up tension between the catheter and the guidewire (until the sheath).First the catheter and then the guidewire were removed.The guidewire had thread/fibershaped part in the tip.It is unknown when exactly this occured during use.The patient is doing well and was discharged.Additional information received 15-mar-2022: based on new information the location of the break is malleable and there was no complete separation.
Event or Problem Description
Nature of complaint: the atherectomy device as well as the guidewire was prepared as per indications in the ifu.The catheter was used successfully for approximately 5-6 back and forth runs.As the physician tried to remove the catheter over the guidewire, a big resistance was observed.The physician believed the guidewire was stuck in the catheter.The user turned the motor back on to ease up tension between the catheter and the guidewire (until the sheath).First the catheter and then the guidewire were removed.The guidewire had thread/fibershaped part in the tip.It is unknown when exactly this occured during use.The patient is doing well and was discharged.Additional information received 15-mar-2022: based on new information the location of the break is malleable and there was no complete separation.Additional information received 26-apr-2022: apologies for the discrepancy, yes the correct lot number is 11118116.

• 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
• Manufacturer (Section G): LAKE REGION MEDICAL LIMITED; butlersland; new ross; co. wexford, Y34 K 825; EI Y34 K825
• Manufacturer Contact: suzanne foley ; butlersland; new ross; co. wexford, Y34 K-825 ; EI Y34 K825
• MDR Report Key: 14164041
• Report Number: 9681477-2022-00005
• Device Sequence Number: 14164604
• Product Code: DQX
• UDI-Device Identifier: 10845225002760
• UDI-Public: (01)10845225002760(17)220304(10)11118116
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2022
• Device Model Number: OFG2524LF
• Device Catalogue Number: PG14300LF
• Device Lot Number: 11118116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 04/26/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown