MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); ST Segment Elevation (2059)

Event Date 12/09/2014

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files did not show any system notices for the date of event.Files also showed at least fourteen injections were performed with catheter 2af284 / 70009-62.Upon visual inspection of flexcath advance sheath 4fc12 / 39914-18, results showed the device was intact with no apparent issues.The reported leaking valve/air ingress could not be reproduced.Multiple aspirations / injections were performed without air bubbles or leaks; hemostatic valve was leak tight.A clinical issue occurred and was resolved during procedure (st elevation / embolism).In conclusion, the reported issue (air ingress) has not been confirmed through testing.A clinical event occurred during procedure.Flexcath advance 4fc12 / 39914-18 passed the returned product inspection as per specification.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, isolation of the pvs was conducted using the arctic front advance (number of ablations performed: three times to lspv, two times to lipv, two times to rspv, two times to ripv).After that, the sheath was pulled to the ra and cti was treated using a competitor product.To check the potentials in the pvs, the sheath was inserted into the la and the mapping catheter only was placed in the sheath.Disappearance of potentials was checked in the following order: lspv, the lipv and then ripv.Ecg showed st elevation in the ripv.Cag was therefore conducted.Neither stenosis nor air was confirmed there.Ten minutes later, st level went back to normal.Air was found below the pa valve through fluoroscopy during the cag performing.When the mapping catheter was inserted in the sheath, negative pressure was given to flush the sheath, but no further air was found.The patient's conscious level was normal.No abnormality was confirmed in his visual field or movements of the limbs and body.The patient had no breathing difficulty either.The case was completed with cryo.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6888399
• MDR Text Key: 87863759
• Report Number: 3002648230-2017-00528
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2016
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 39914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 54 YR