MAUDE Adverse Event Report: LAKE REGION MEDICAL JETSTREAM JETWIRE; WIRE, GUIDE, CATHETER

Model Number	011525-001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch report is being filed based on the results of the device evaluation.As received, the specimen consisted of one-1 each jetwire gw xtra sup300-014; 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 extensive kink/bend damage of varying severity and frequency scattered over the length of the device.The distal coil and core region presented bend and ductile overload fracture damage.The ptfe coating presented scraped/frayed coating in the vicinity of the kink bend damage with no evidence of coating removal.The proximal coil to core wire joint appears to be correct and intact by visual examination and by non-destructive testing.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.Based on the information provided and the evidence presented, it is not possible to determine the timing of the damage as presented.At this time, it is not possible to assign a definitive root cause for the event as reported.The patient information was not provided at the time of this report.If there is any further relevant information received, a follow up medwatch report will be submitted.
Event or Problem Description
Event description: material was defective.The guidewire that was routed with the catheter was not reported.

• Brand Name: JETSTREAM JETWIRE
• Common Device Name: 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: 15006765
• Report Number: 2126666-2022-00027
• Device Sequence Number: 2517092
• Product Code: DQX
• UDI-Device Identifier: 08714729888789
• UDI-Public: 08714729888789
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K140485
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2022

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: 08/31/2021
• Device Model Number: 011525-001
• Device Catalogue Number: PV014300
• Device Lot Number: 11054637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2018
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown