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

Model Number	011525-001
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received for evaluation and was reported to have been disposed; 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 warnings: prior to use, ensure that the guidewire is compatible with the catheter or interventional device lumen.Guidewire manipulation within the vasculature should always be performed under fluoroscopic guidance.Do not advance, withdraw, or torque the guidewire against resistance as tip separation or breakage may occur.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.
Event or Problem Description
When using the jetstream 2.4 catheter, it was difficult to remove the wire, being locked.The entire system was removed and the jetwire wire still wouldn't come off.To complete the procedure, it was necessary to use another jetstream 2.1 catheter.In the first pass of the wire, it did not present any resistance, in the second time a greater resistance was perceived in lowering the catheter by the wire and for that reason the procedure with jetstream 2.1 was not concluded.

• Brand Name: JETSTREAM JETWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): LAKE REGION MEDICAL; 340 lake hazeltine drive; chaska, mn
• MDR Report Key: 10178799
• Report Number: 2126666-2020-00039
• Device Sequence Number: 19503209
• Product Code: DQX
• UDI-Device Identifier: 08714729888772
• UDI-Public: 08714729888772
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K140485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2020

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: 11/30/2021
• Device Model Number: 011525-001
• Device Catalogue Number: PV014300
• Device Lot Number: 11092383
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1