MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC; INTRODUCER, CATHETER

Lot Number 60824099

Device Problems Leak/Splash (1354); Migration or Expulsion of Device (1395)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/07/2017

Event Type  malfunction  

Event Description

The distal portion of sheath came off the right femoral sheath and was located in the right internal iliac artery.Doctor asked for a snare to attempt to retrieve, but then on subsequent angio, the portion had migrated to the right hypogastric.No attempt was made to retrieve as the position of the retained piece would not cause harm to the patient.Patient was stable throughout and transported to cvicu.During procedure the balloon dilated near to end of full expansion, and surgeons were not able to hold for several seconds.Therefore, it was determined that with a little bit of root shot, there was some mild paravalvular leakage.Therefore, surgeons got a new balloon after removal of the other one and did a post dilatation with excellent results.Surgeons removed the introducer under fluoro and noticed that the marker ring at the tip had gone down into the right common iliac.Surgeons had decided that they were going to snare it, but in the meantime, partially reversed heparin used and the introducer was removed on the left.The perclose was cinched down with good results.Surgeons then turned their attention to the radial marker piece.Under fluoroscopic diagnosis, surgeons noticed that it was in the hypogastric, and was not a threat to patient.

• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• MDR Report Key: 6904637
• MDR Text Key: 87794757
• Report Number: 6904637
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 60824099
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/06/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CARDIAC DRUGS; DIAGNOSTIC CATHETER, TEMPORARY VENOUS PACING WIRE,
• Patient Age: 79 YR
• Patient Weight: 128