BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARTER GUIDEWIRE

    MDR report key: 20143116 · Received September 5, 2024

    Report

    Report Number
    9681477-2024-00014
    Event Type
    Death
    Date Received
    September 5, 2024
    Report Date
    September 27, 2024
    Manufacturer
    LAKE REGION MEDICAL LIMITED
    Product Code
    DQX
    PMA / PMN Number
    K935170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE END USER DID NOT PROVIDE LOT TRACEABILITY; THEREFORE, (B)(6) MEDICAL WAS UNABLE TO REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING, AND PACKAGING OF THIS PRODUCT.

    Additional Manufacturer Narrative · 0

    THERE WAS NOT ENOUGH INFORMATION AVAILABLE TO PROVIDE AN ACCURATE ACCOUNT ON WHAT MOVEMENTS WERE POSSIBLE THROUGHOUT THE SURGERY. FROM WHAT INFORMATION WAS GIVEN, IT CAN BE CONFIRMED THAT THE GUIDEWIRE WAS NOT DEFECTIVE AND WAS NOT THE CAUSE OF THE SURGERY'S OUTCOME. THE END USER DID NOT PROVIDE LOT TRACEABILITY; THEREFORE, LAKE REGION MEDICAL WAS UNABLE TO REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING, AND PACKAGING OF THIS PRODUCT.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: ECN EVENT DESCRIPTION: PHYSICIAN CALLED ME. SAID HE IS INVOLVED IN A MALPRACTICE SUIT. SAID HE USED A 'STARTER' WIRE DURING A HEART CATH. SAID HE WAS LOOKING FOR PRODUCT INFORMATION AND TO SEE IF THE WIRE COULD MAKE A PARTICULAR TURN. I ASKED IF HE COULD PROVIDE MORE DETAIL ON THE WIRE. HE SAID THE TIP WAS A 3MM SEMI-CIRCLE WIRE. I ADVISED HIM ON THE TIP SHAPES THAT WE SELL FOR OUR PERIPHERAL STARTER FAMILY OF WIRES: STRAIGHT TIP, J TIP, ROSEN, BENTSON AND NEWTON. I ALSO SAID THE CLOSEST WIRE WE HAVE TO WHAT HE IS DESCRIBING IS A J WIRE. HE CLAIMS THAT IS NOT THE WIRE HE USED. I LISTED THE FIXED CORE J WIRE ON THIS REPORT, AS ITS THE WIRE THAT IS ORDERED MOST FREQUENTLY AT THE ACCOUNT. HE IS INTERESTED IN THE DEVICE SPECIFICATIONS OF THE STARTER WIRE, AND TORQUE RESPONSIVENESS AND GENERAL WIRE CAPABILITIES, AS HE BELIEVES THAT THE WIRE HE USED COULD NOT HAVE MADE THE TURN THAT WOULD HAVE CAUSED THE DEATH. PATIENT PRESENT AT TIME OF EVENT?: YES PATIENT COMPLICATIONS: DEATH IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION?: NO MEDICAL OR SURGICAL INTERVENTIONS: NA PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN PATIENT OUTCOME: UNKNOWN PROCEDURE DATE-UNKNOWN TIME OF EVENT - OTHER: NOT KNOWN TIME OF THE EVENT: OTHER EVENT DATE: NO VALUE FOUND. AS REPORTED DEVICE CODES: 1163: DAMAGED/DEFECTIVE. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED, PROCEDURE - NO INFORMATION AVAILABLE. PATIENT OUTCOME: F02: DEATH. 1. WAS THERE FAILURE MODE ATTRIBUTED TO THE DEVICE? A. PLEASE EXPLAIN FURTHER WHAT DOES "THE WIRE HE USED COULD NOT HAVE MADE THE TURN THAT WOULD HAVE CAUSED THE DEATH" MEANS. A: IT IS MY UNDERSTANDING OF THE PHYSICIAN'S STATEMENT - THAT HE CLAIMS THAT THE WIRE IN QUESTION COULD NOT HAVE MADE THE TURNS NEEDED TO CANNULATE TO THE AREA THAT CAUSED THE PATIENT'S DEATH. 2. WAS THERE ANY DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 3. WAS THERE ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 4. WAS THE PRODUCT INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 5. WILL THE DEVICE BE RETURNED FOR ANALYSIS? A: NO. 6. WHAT IS THE LOT# OR CATALOGUE# FOR THE DEVICE? A: LOT INFORMATION IS NOT KNOWN - UPN # IS: M001491211. 7. WHAT ACTIONS WERE PERFORMED ON THE GUIDEWIRE TO PREPARE THE GUIDEWIRE FOR USE? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 8. WERE ANY PROBLEMS NOTED DURING PREPARATION? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 9. WAS THE GUIDEWIRE PREPPED PROPERLY ACCORDING TO THE IFU? A: INFORMATION IS NOT KNOWN. 10. LIST/NAME ANY DEVICE THAT WAS USED WITH THE GUIDEWIRE. A: A 6F TERUMO GLIDE SHEATH WAS USED IN ACCORDANCE TO THE IMAGE ABOVE REGARDING THE PROCEDURE NOTES. OTHER DEVICES WERE USED IN THE PROCEDURE; HOWEVER, I DO NOT KNOW IF THIS DEVICE WAS USED ALONE OR IN CONJUNCTION WITH OTHER CATHETERS ETC. 11. WAS THERE DIFFICULTY ADVANCING THE DEVICES OVER THE GUIDE WIRE? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 12. WAS THERE ANY DIFFICULTY ADVANCING THE GUIDEWIRE TOWARDS THE TARGET LESION? A: INFORMATION IS NOT KNOWN. IT IS MY UNDERSTANDING AS THE PHYSICIAN DESCRIBES IT, THAT THERE IS NO WAY THAT THIS WIRE COULD TAKE THE TURN THAT WOULD BE REQUIRED TO LEAD THE WIRE TO THE VASCULAR BED THAT CAUSED THE PATIENT'S DEATH. 13. IS THERE ANY TARGET LESION/TARGET LESION CHARACTERISTIC INFORMATION AVAILABLE? A: INFORMATION IS NOT KNOWN ABOUT THE INTENDED TARGET LESION. THE PHYSICIAN DID DESCRIBE "A SPONTANEOUS POSTERIOR CEREBRAL ARTERY HEMORRHAGE". 14. WAS UNUSUAL FORCE EVER REQUIRED WHEN USING THE DEVICE? A: INFORMATION IS NOT KNOWN. NOTHING WAS STATED. 15. WAS THE DEVICE REMOVED EASILY AND INTACT FROM THE PATIENT? A: INFORMATION IS NOT KNOWN, NOTHING WAS STATED 16. WHAT IS THE DATE OF OCCURRENCE OF THE EVENT? A: INFORMATION WAS NOT DISCLOSED 17. WHAT IS THE PHYSICIAN'S OPINION OF THE RELATIONSHIP BETWEEN THE DEVICE AND PATIENT DEATH? A: THE PHYSICIAN BELIEVES THAT THIS WIRE COULD NOT HAVE CAUSED THE PERFORATION THAT CAUSED THE DEATH.

    Description of Event or Problem · 0

    EVENT DESCRIPTION: ECN EVENT DESCRIPTION: PHYSICIAN CALLED ME. SAID HE IS INVOLVED IN A MALPRACTICE SUIT. SAID HE USED A 'STARTER' WIRE DURING A HEART CATH. SAID HE WAS LOOKING FOR PRODUCT INFORMATION AND TO SEE IF THE WIRE COULD MAKE A PARTICULAR TURN. I ASKED IF HE COULD PROVIDE MORE DETAIL ON THE WIRE. HE SAID THE TIP WAS A 3MM SEMI-CIRCLE WIRE. I ADVISED HIM ON THE TIP SHAPES THAT WE SELL FOR OUR PERIPHERAL STARTER FAMILY OF WIRES: STRAIGHT TIP, J TIP, (B)(6). I ALSO SAID THE CLOSEST WIRE WE HAVE TO WHAT HE IS DESCRIBING IS A J WIRE. HE CLAIMS THAT IS NOT THE WIRE HE USED. I LISTED THE FIXED CORE J WIRE ON THIS REPORT, AS ITS THE WIRE THAT IS ORDERED MOST FREQUENTLY AT THE ACCOUNT. HE IS INTERESTED IN THE DEVICE SPECIFICATIONS OF THE STARTER WIRE, AND TORQUE RESPONSIVENESS AND GENERAL WIRE CAPABILITIES, AS HE BELIEVES THAT THE WIRE HE USED COULD NOT HAVE MADE THE TURN THAT WOULD HAVE CAUSED THE DEATH. PATIENT PRESENT AT TIME OF EVENT? YES, PATIENT COMPLICATIONS: DEATH IN THE PHYSICIAN'S OPINION, DID THE DEVICE OR PROCEDURE CAUSE OR CONTRIBUTE TO THE PATIENT COMPLICATION? NO MEDICAL OR SURGICAL INTERVENTIONS: NA PATIENT ADMITTED TO HOSPITAL BEYOND THE STANDARD OF CARE: UNKNOWN PATIENT OUTCOME: UNKNOWN PROCEDURE DATE-UNKNOWN TIME OF EVENT - OTHER: NOT. KNOWN TIME OF THE EVENT: OTHER. EVENT DATE: NO VALUE FOUND. AS REPORTED DEVICE CODES: 1163: DAMAGED/DEFECTIVE. AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED, PROCEDURE - NO INFORMATION AVAILABLE. PATIENT OUTCOME: F02: DEATH. 1. WAS THERE FAILURE MODE ATTRIBUTED TO THE DEVICE? A. PLEASE EXPLAIN FURTHER WHAT DOES "THE WIRE HE USED COULD NOT HAVE MADE THE TURN THAT WOULD HAVE CAUSED THE DEATH" MEANS. A: IT IS MY UNDERSTANDING OF THE PHYSICIAN'S STATEMENT - THAT HE CLAIMS THAT THE WIRE IN QUESTION COULD NOT HAVE MADE THE TURNS. NEEDED TO CANNULATE TO THE AREA THAT CAUSED THE PATIENT'S DEATH. 2. WAS THERE ANY DAMAGE NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 3. WAS THERE ANY REPORTED DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 4. WAS THE PRODUCT INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 5. WILL THE DEVICE BE RETURNED FOR ANALYSIS? A: NO. 6. WHAT IS THE LOT# OR CATALOGUE# FOR THE DEVICE? A: LOT INFORMATION IS NOT KNOWN - UPN # IS: M001491211. 7. WHAT ACTIONS WERE PERFORMED ON THE GUIDEWIRE TO PREPARE THE GUIDEWIRE FOR USE? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 8. WERE ANY PROBLEMS NOTED DURING PREPARATION? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 9. WAS THE GUIDEWIRE PREPPED PROPERLY ACCORDING TO THE IFU? A: INFORMATION IS NOT KNOWN. 10. LIST/NAME ANY DEVICE THAT WAS USED WITH THE GUIDEWIRE. A: A 6F TERUMO GLIDE SHEATH WAS USED IN ACCORDANCE TO THE IMAGE ABOVE REGARDING THE PROCEDURE NOTES. OTHER DEVICES WERE USED IN THE PROCEDURE; HOWEVER, I DO NOT KNOW IF THIS DEVICE WAS USED ALONE OR IN CONJUNCTION WITH OTHER CATHETERS ETC. 11. WAS THERE DIFFICULTY ADVANCING THE DEVICES OVER THE GUIDE WIRE? A: INFORMATION IS NOT KNOWN - AND NOTHING WAS STATED. 12. WAS THERE ANY DIFFICULTY ADVANCING THE GUIDEWIRE TOWARDS THE TARGET LESION? A: INFORMATION IS NOT KNOWN. IT IS MY UNDERSTANDING AS THE PHYSICIAN DESCRIBES IT, THAT THERE IS NO WAY THAT THIS WIRE COULD TAKE THE TURN THAT WOULD BE REQUIRED TO LEAD THE WIRE TO THE VASCULAR BED THAT CAUSED THE PATIENT'S DEATH. 13. IS THERE ANY TARGET LESION/TARGET LESION CHARACTERISTIC INFORMATION AVAILABLE? A: INFORMATION IS NOT KNOWN ABOUT THE INTENDED TARGET LESION. THE PHYSICIAN DID DESCRIBE "A SPONTANEOUS POSTERIOR CEREBRAL ARTERY HEMORRHAGE". 14. WAS UNUSUAL FORCE EVER REQUIRED WHEN USING THE DEVICE? A: INFORMATION IS NOT KNOWN. NOTHING WAS STATED. 15. WAS THE DEVICE REMOVED EASILY AND INTACT FROM THE PATIENT? A: INFORMATION IS NOT KNOWN, NOTHING WAS STATED 16. WHAT IS THE DATE OF OCCURRENCE OF THE EVENT? A: INFORMATION WAS NOT DISCLOSED 17. WHAT IS THE PHYSICIAN'S OPINION OF THE RELATIONSHIP BETWEEN THE DEVICE AND PATIENT DEATH? A: THE PHYSICIAN BELIEVES THAT THIS WIRE COULD NOT HAVE CAUSED THE PERFORATION THAT CAUSED THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369443 STARTER GUIDEWIRE GUIDEWIRE DQX LAKE REGION MEDICAL LIMITED M001491211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death