MAUDE Adverse Event Report: UNKNOWN LUNDERQUIST GUIDEWIRE; WIRE, GUIDE, CATHETER

Device Problem Difficult or Delayed Positioning (1157)

Patient Problems Hemorrhage/Bleeding (1888); Low Oxygen Saturation (2477)

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this melody transcatheter pulmonary bioprosthetic valve, there was difficulty maintaining the lunderquist guidewire in position.Blood was noted in the endotracheal tube, and an angiogram and echocardiogram were performed.No blood was seen in the chest.The patient desaturated moderately; therefore the procedure was aborted.One day post-implant, no bleeding was reported and the patient was doing well.The patient will be evaluated for another valve replacement.There is no allegation against the function of any medtronic product.It was reported that the guidewire perforated the pulmonary artery.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: LUNDERQUIST GUIDEWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17536148
• MDR Text Key: 321160782
• Report Number: MW5143038
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1