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

Model Number	M001492981
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received at the time of this report; therefore, no physical analysis of the device can be performed.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.As noted in the device instructions for use (dfu), "free movement of the guidewire within the catheter is an important feature of a steerable guidewire system because it gives the user valuable tactile information.Test the system for any resistance prior to use." 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 there is any further relevant information provided, a follow up medwatch report will be submitted.
Event or Problem Description
Description of event: made one pass with jetstream catheter wire and the device got stuck on the way i had to pull the wire and catheter out as one whole unit.The procedure was completed using another jetstream catheter and three-way wire.
Additional Manufacturer Narrative
Device evaluation: as received, the specimen consisted of one-1 each 300-014 gw, long taper guidewire; returned coiled, loose 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 a ductile, tensile overload fracture with torsional loading of the distal coil wire at the proximal coil to core wire joint and a ductile, tensile overload fracture of the core wire near the distal tip joint; the distal coil and distal tip joint was not returned with the specimen device.The supporting documentation indicated the fracture occurred when separating the thruway from the jetstream catheter after removing both devices from the patient as a unit.The specimen also presented multiple kinks/bends of varying severity and frequency scattered over the length of the device.The ptfe coating in the vicinity of many of the kink damage sites and scattered over the distal 175cm was scraped, frayed and removed with visible damage to the exposed metallic surface of the core wire.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 device instructions for use (dfu) warnings, prior to use, ensure that the guidewire size is compatible with the catheter or interventional device lumen.Do not advance, withdraw, or torque the guidewire against resistance as tip separation or breakage may occur.If the guidewire tip does not rotate freely, do not turn the wire 360 degrees in one direction.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 there is any further relevant information provided, a follow up medwatch report will be submitted.

• Brand Name: THRUWAY GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska MN 55318
• MDR Report Key: 11819891
• Report Number: 2126666-2021-00014
• Device Sequence Number: 16956324
• Product Code: DQX
• UDI-Device Identifier: 08714729717195
• UDI-Public: 08714729717195
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K042338
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 02/29/2024
• Device Model Number: M001492981
• Device Catalogue Number: 49-298
• Device Lot Number: 6241283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR