MAUDE Adverse Event Report: LAKE REGION MEDICAL THRUWAY GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number M001492971

Device Problems Break (1069); Flaked (1246); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/05/2021

Event Type  Injury  

Manufacturer Narrative

If there is any further relevant information received, a follow up medwatch report will be submitted.

Event Description

Complaint summary: it was reported that unretrieved device fragments and device detachment was encountered.The target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 300cm thruway guidewire was advanced for treatment.However, it was noted that the end of the wire broke off in the distal on its own accord, but the broken fragment could not be retrieved.The patient fully recovered.Medical/surgical interventions: retrieval attempted, but wire fragment lodged in a very distal, small branch of an artery.Patient outcome: fully recovered.Patient admitted to hospital beyond standard of care? no.Additional information was received on october 19, 2021: something caused the wire to break but the cause cannot be determined.The procedure was completed with other implantable not related to the wire breakage.We inserted other wires post the removal of the broken thruway wire.No additional procedural information was provided.It was reported that everything was stock standard.Additional information was received on october 26, 2021: are there any plans in place to bring the patient back in to remove the wire fragment? no plans to bring patient back.No need at this stage.

Manufacturer Narrative

Device evaluation: as received, the specimen consisted of one-1 each 300-014 short taper g.W.; returned reloaded into the dispenser assembly, and double-bagged within "zip-lock" style poly biohazard pouches.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.During manufacturing and packaging of this product the operators are instructed to 100% visually inspect for any obvious defect prior to shipment.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.The specimen presented torsional overload with tensile loading fractures of the core wire and distal coil wire and several bends of varying severity and frequency scattered over the length of the device with scraped, frayed ptfe coating in the bend regions.Our investigation was unable to confirm that the product did not meet specification prior to shipment.The investigation concluded that the product met specification at the time of shipment.As noted in the precaution portion of the device instructions for use, "do not torque, advance or withdraw the guidewire if significant resistance is felt.Torqueing, advancing or withdrawing a guidewire against significant resistance may cause vessel damage, guidewire damage and/or guidewire tip separation." as noted in the warnings portion of the device instructions for use, "attention should be paid to guidewire movement in the vessel.Before a wire is moved or torqued, the tip movement should be examined under fluoroscopy.Do not torque a wire without observing corresponding movement of the tip.Always advance or withdraw a wire slowly.Never push, auger, or withdraw a guidewire which meets resistance or the guidewire may perforate the vessel if forced against resistance.Resistance may be felt tactilely or noted by tip buckling under fluoroscopy." at this time, it is not possible to assign a definitive root cause for the event as reported.Based on the information provided, it appears that clinical and/or procedural factors have contributed to the event as reported.If any further relevant information is received, a follow up medwatch report will be submitted.

Manufacturer Narrative

Completed section d9-device available for evaluation and the date returned to manufacturer.

• Brand Name: THRUWAY GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer (Section G): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: sharon seifert ; 340 lake hazeltine drive; chaska, MN 55318 ; 9526418518
• MDR Report Key: 12705100
• MDR Text Key: 278613622
• Report Number: 2126666-2021-00044
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08714729717188
• UDI-Public: 08714729717188
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042338
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: M001492971
• Device Catalogue Number: 49-297
• Device Lot Number: 5899835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2021
• Initial Date FDA Received: 10/27/2021
• Supplement Dates Manufacturer Received: 11/24/2021; 11/24/2021
• Supplement Dates FDA Received: 12/01/2021; 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male